Medical fluid injection system and method for guided setup

ABSTRACT

One embodiment provides a method of using contextual lighting to assist a user of a medical fluid injection system. In this embodiment, the method includes providing a lighted display in proximity to a component of the injection system during setup of the medical fluid injection system. If the user has properly performed a setup function that is associated with the component of the injection system, the method further comprises providing a first visual indication on the lighted display. If the user has not properly performed the setup function that is associated with the component of the injection system, the method further comprises providing a second visual indication on the lighted display.

RELATED APPLICATIONS

This application is the national stage filing of correspondinginternational application number PCT/US2006/060983, filed Nov. 16, 2006which claims priority to and the benefit of U.S. Provisional ApplicationNo. 60/738,829 filed Nov. 21, 2005, all of which are hereby incorporatedby reference.

FIELD OF THE INVENTION

This application relates generally to an improved injector system forinjecting medical fluids, such as radiographic contrast fluids,particularly for angiography.

BACKGROUND OF THE INVENTION

Angiography is a procedure used in the diagnosis and treatment ofcardiovascular conditions including abnormalities or restrictions inblood vessels, the network of passageways through which blood travels ina human or animal body. During angiography, a radiographic contrastmaterial is injected through a catheter into a vein or artery, whichthen passes to vascular structures in fluid communication with the veinor artery. When X-rays are passed through the region of the body intowhich the contrast material is injected, they are absorbed by thecontrast material, providing radiographic images of the desired vascularstructure(s). The images can be recorded on film or video tape and/ordisplayed on a fluoroscope monitor. The images can be used for manypurposes, as for example, diagnostics and for therapeutic proceduressuch as angioplasty, wherein a balloon is inserted into a vascularsystem and inflated to open a stenosis.

The contrast material can be injected into the catheter by either manualor automated injection systems. While the apparatus for injecting thecontrast material can vary, most current systems include a syringeoperatively connected with the catheter. The syringe has a chamber forholding the contrast material and a plunger reciprocally moveable withinthe chamber. The contrast material is suctioned into the chamber whenthe plunger is moved to create a partial vacuum within the chamber. Areversal of the plunger direction first forces air out of the chamberand then delivers the contrast material to the catheter at a rate andvolume determined by the speed of movement of the plunger.

In a manual system the user or operator loads the syringe and ejects airfrom the chamber before connecting the syringe to the catheter. The userof a manual system adjusts the rate and volume of injection by alteringthe manual force applied to the plunger. The maximum injection pressurefor manual systems typically limited to about 150 p.s.i. (i.e. themaximum pressure that can be applied by the human hand), and the maximumquantity of fluid is about 12 cc. Such manual systems typically do notaccommodate any safety features such as the restriction or prevention ofinjections outside of predetermined injection parameters (such as rateor pressure), and generally do not include active sensors or alarms todetect air bubbles or other hazards.

Angiography can include the injection of fluids other than the contrastmaterial. For example, a saline flush and/or the injection of fluidmedications may be desired. One of the most commonly used manualinjection systems includes a valve mechanism having a plurality ofmanually activated valves that the operator selectively opens and closesto direct flow of the desired fluids into or out of fluid channelsconnected to the syringe or catheter. When the operator aspirates orinjects the contrast fluid into or out of the syringe chamber, the fluidflows through the path of least resistance as directed by the relativepositions of the valves. When changing the valve positions, one or morefluids may be selectively injected.

Certain automated fluid delivery systems provide a control panel or userinterface that may be used, or operated, by a trained professional, suchas a physician. The professional may enter one or more injectionparameters using the control panel. The user interface may comprise atouch-panel screen. These parameters can then be used during a patientinjection procedure. Certain automated injection systems require entryof the following injection parameters: the volume of contrast materialto be injected, the flow rate of injection, the maximum permittedinjection pressure and the rate of change of injection flow rate (i.e.the rise time). The control panel may be connected directly to aninjector head or to a patient bed table.

SUMMARY OF THE INVENTION

According to certain embodiments, there is provided an injection systemhaving a dual-syringe assembly. One syringe is capable of holding afirst fluid medium (such as contrast), and the second syringe is capableof holding a second fluid medium (such as saline). Each syringecomprises independent inlet and outlet ports. The inlet port is used tofill the syringe with fluid, and the outlet port is used to expel fluidfrom the syringe.

According to certain embodiments, there is provided an injection systemthat uses a disposable cassette providing fluid connections to theinjection system. Fluid that is dispensed by the injection system isprovided to the patient via the disposable cassette. One or more tubingcomponents are coupled between the injection system and the disposablecassette. Valves, and particularly pinch valves, may be used to preventflow of fluid to the disposable cassette in certain scenarios, and toalso prevent backflow of fluid. The disposable cassette provides fluidconnections between the cassette and the injection system, and alsoprovides connections for tubing that may be connected to the patient.The disposable cassette may be a single-use component that is discardedafter each patient use.

According to certain embodiments, there is provided an injection systemthat provides multiple display devices. In this aspect, a small displaydevice may be provided directly on the injector, while a larger displaydevice (main control panel) may be located remotely from the smalldisplay device. The small display device may be used to provide setupinformation, error and troubleshooting information, and other systeminformation, and it may also be used to obtain certain input from theuser, such as bottle or bag size. In one aspect, there is furtherprovided an additional remote display that may be the size of a personaldigital assistant (PDA). This additional remote display may be incommunication with the main control panel via a wireless connection,according to one embodiment. A physician may utilize this additionalremote display with flexibility, because the display is mobile. Due toits size, the additional display is also very portable and convenient touse. In one implementation, the additional display provides both userinput capabilities and display output capabilities.

According to certain embodiments, there is provided an injection systemthat implements a method for using contextual lighting to assist a userof a fluid injection system. In these embodiments, the method comprisesproviding a first visual indicator on the fluid injection systeminstructing the user to perform a setup function on the system,providing a second visual indicator on the system if the user hasimproperly performed the setup function, and providing a third visualindicator on the system if the user has properly performed the setupfunction.

According to certain embodiments, there is provided an injection systemhaving an improved graphical user interface (GUI) for display within adisplay device in the system. One aspect also provides customizable areainjection buttons, icons for fast navigation, and a range of predefinedicons. In some embodiments, the GUI provides an interface for the userduring either guided or express setup modes of the system. In theseembodiments, the functionality of the GUI may be synchronized with oneor more aspects of the contextual lighting. Various other items in theGUT provide an improved interface with the user.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages will be apparent from the description anddrawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating a preferred embodiment of anangiographic injector system.

FIGS. 2A-2G are diagrams illustrating operations of the system of FIG.1.

FIG. 3 is an electrical block diagram of the control system of theinjector system of FIG. 1.

FIG. 4 illustrates front panel controls and displays of a preferredembodiment of the injector system.

FIGS. 5A and 5B are side and partial top perspective views of a remotecontrol of the system of FIG. 1.

FIG. 6 is a perspective view of a foot operated remote control.

FIGS. 7A-7D illustrate the operation of the inlet check valve andmanifold during contrast fill, air purge, and patient inject operations.

FIGS. 8A-8C illustrate operation of the inlet check valve in greaterdetail.

FIGS. 9A and 9B are perspective views illustrating a second embodimentconfiguration of an angiographic injector system.

FIG. 10 is a mechanical block diagram illustrating the mountingconfiguration of the portions of the system disclosed in FIG. 9.

FIGS. 11A and 11B are an electrical block diagram of the control systemand electrical functions of the system of FIGS. 9 and 10.

FIG. 12 is an electrical block diagram of the injector motor controlportion of the control system of FIG. 11.

FIG. 13 is an electrical block diagram of the safety circuits associatedwith the peristaltic pump motor control portion of the control system ofFIG. 11.

FIG. 14 is an illustration of a Power Up screen of the display of thesystem of FIG. 11.

FIG. 15 is an illustration of a Back Calibration screen of the displayof the system of FIG. 11.

FIG. 16 is an illustration of a Check Screen of the display of thesystem of FIG. 11.

FIG. 17 is an illustration of a Forward Calibration screen of thedisplay of the system of FIG. 11.

FIG. 18 is an illustration of a First Start-Up Instruction screen of thedisplay of the system of FIG. 11.

FIG. 19 is an illustration of a Second Start-Up Instruction screen ofthe display of the system of FIG. 11.

FIG. 20 is an illustration of a Third Start-Up Instruction screen of thedisplay of the system of FIG. 11.

FIG. 21 is an illustration of a Fourth Start-Up Instruction screen ofthe display of the system of FIG. 11.

FIG. 22 is an illustration of a Ready to Fill Syringe screen of thedisplay of the system of FIG. 11.

FIG. 23 is an illustration of a Syringe Filling Notice screen of thedisplay of the system of FIG. 11.

FIG. 24 is an illustration of a Purging Notice screen of the display ofthe system of FIG. 11.

FIG. 25 is an illustration of a Line Purge Instruction screen of thedisplay of the system of FIG. 11.

FIG. 26 is an illustration of a Purging Line Notice screen of thedisplay of the system of FIG. 11.

FIG. 27 is an illustration of a Final Saline Flush Instruction screen ofthe display of the system of FIG. 11.

FIG. 28 is an illustration of a Saline Flushing Notice screen of thedisplay of the system of FIG. 11.

FIG. 29 is an illustration of a Final Start-Up screen of the display ofthe system of FIG. 11.

FIG. 30 is an illustration of the MAIN display screen of the system ofFIG. 11.

FIG. 31 is an illustration of the MAIN display screen of FIG. 30illustrating operation in an injecting mode.

FIG. 32 is an illustration of the MAIN display screen of FIG. 30illustrating the keypad that is displayed when the Fixed Rate mode ofoperation is selected.

FIG. 33 is an illustration of the MAIN display screen of FIG. 30illustrating the keypad that is displayed when the Variable Rate mode ofoperation is selected.

FIG. 34 is an illustration of the MAIN display screen of FIG. 30,illustrating operation in a Manual Purging mode.

FIG. 35 is an illustration of the MAIN display screen of FIG. 30,illustrating operation in a Manual Refilling mode.

FIGS. 36A-C illustrate comparative graphs for default injectionparameter values for Flow Rate Limits determined by algorithms relatingto patient weight.

FIGS. 37A-C illustrate comparative graphs for default injectionparameter values for Volume Limits determined by algorithms of thisinvention relating to patient weight.

FIG. 38 is a diagrammatic flow chart illustrating the process used todetermine the patient related default injection parameters of FIGS. 36and 37.

FIGS. 39A-C are views of a powered, dual-syringe contrast injectionsystem, according to one embodiment.

FIGS. 40A-B and 41A-B are perspective views of certain embodiments ofdisposable fluid connections that may be used in a powered injectionsystem.

FIG. 42 is a perspective view of a powered injection system thatincludes a syringe and a peristaltic pump, according to one embodiment.

FIG. 43-FIG. 54 illustrate various embodiments of screen displays thatmay be provided within a graphical user interface (GUI) in a poweredinjection system.

FIG. 55A is a perspective view of one embodiment of a valve that may beused with a powered injection system.

FIG. 55B is a perspective view of another embodiment of a valve that maybe used with a powered injection system.

FIG. 56 is a perspective view of one embodiment of a hand controllerthat may be used with a powered injection system.

DETAILED DESCRIPTION

As will be appreciated upon a more detailed description herein, theprinciples of various embodiments of this invention can be applied tomany different physical configurations of automated injector systems.Example of such systems will be generally described below. Referring tothe Drawings, FIG. 1 shows an injector system 10 for injectingradiographic contrast material into a blood vessel under interactivephysician control. System 10 includes main console 12, hand held remotecontrol 14, syringe holder 16, syringe body 18, syringe plunger 20,radiographic material reservoir (bottle) 22, one-way valve 24, manifold26, high pressure tube 28, catheter 30, patient medication port 32,three-way stop-cock 34, T-connector 36, pressure transducer 38,stop-cock 40, tubing 42, peristaltic pump 44, saline check valve 46,waste check valve 48, saline bag 50, waste bag 52, and bag support rack54.

Console 12 houses the electrical controls for system 10, together withthe motors which drive piston 20 and peristaltic pump 44. On the frontsurface of console 12, user interface 55 provides control switches 56and display 58 through which the user may enter control settings andmonitor the operational state of system 10. The console can befree-standing, preferably configured for mounting on a transport cartassembly.

Electrical power is provided to all electrical components of the systemby an appropriate power supply which also provides electrical safetyisolation from the main power source. The power supply can be locatedwithin the console 12, but is preferably mounted separately therefromeither on a wall or on a mounting cart.

Remote control 14 is connected to console 12 by cable 60 (although inother embodiments remote control 14 may be connected by a wirelessconnection such as an RF, infrared optic, or ultrasonic link). Remotecontrol 14 is, in the embodiment shown in FIG. 1, a hand-held controlwhich includes reset and saline push button switches 62 and 64,respectively, and flow rate control lever or trigger 66. By squeezingtrigger 66, the user can provide a command signal to console 12 toprovide a continuously variable injection rate.

Syringe holder 16 projects from the left hand side of console 12.Syringe holder 16 is preferably a clear material, and includes a halfcylindrical back shell 68, a half cylindrical front door 70 (which isshown in open position in FIG. 1), and reservoir holder 72.

Syringe 18 is a transparent or translucent plastic cylinder having itsopen end 74 connected to console 12. Closed end 76 of syringe 18contains two ports: upper port 78 and lower port 80.

Plunger 20 is movable within syringe body 18. Plunger 20 is connectedto, and driven by a motor located within console 12.

Radiographic contrast material reservoir 22 is connected through one-waycheck valve 24 to upper port 78. Radiographic contrast material is drawnfrom reservoir 22 through check valve 24 and upper port 78 into thepumping chamber defined by syringe body 18 and plunger 20. Check valve24 is preferably a weighted one-way valve which permits air to flow fromsyringe body 18 back into reservoir 22, but will not permit radiographiccontrast material to flow from syringe body 18 to reservoir 22. Thispermits automatic purging of air from the system, as will be describedin more detail later.

Lower port 80 of syringe body 18 is connected to manifold 26. Manifold26 includes a spring biased spool valve which normally connectstransducer/saline port 82 and patient port 84. When radiographiccontrast material is to be injected, the pressure of the radiographicmaterial causes the spool valve to change states so that lower port 80is connected to patient port 84.

High pressure tube 28 is a flexible tube which connects patient port 84to catheter 30. Three-way stop-cock 34 is located at the distal end oftube 28. Rotatable luer lock connector 86 is connected to stop-cock 34and mates with luer connector 88 at the proximal end of catheter 30.Stopcock 34 either blocks flow between tube 28 and catheter 30, permitsflow, or connects medication port 32 to catheter 30.

In addition to injecting radiographic material into a patient throughcatheter 30, system 10 also permits other related functions to beperformed. A device for delivering the patient medication (not shown inFIG. 1) may be connected to medication port 32 when medication is to bedelivered through catheter 30 to the patient.

When catheter 30 is in place in the patient, and an injection ofradiographic contrast material is not taking place, pressure transducer38 monitors the blood pressure through the column of fluid which extendsfrom catheter 30, tube 28, patient port 84, manifold 26,transducer/saline port 82, tubing 90, T-connector 36, and tubing 92.Transducer 38 has an associated stop-cock 40 which allows transducer 38to be exposed to atmospheric pressure during calibration and also allowsfor removal/expulsion of trapped air so the dome chamber of transducer38 can be flushed with saline.

Peristaltic pump 44 supplies saline solution from bag 50 through salinecheck valve 46, tubing 42, T-connector 36 and tubing 90 to saline port82. When peristaltic pump 44 is operating to supply saline solution, thesaline solution is supplied through manifold 26 to patient port 84 andthen through tube 28 to catheter 30.

Peristaltic pump 44 also operates in an opposite direction to draw fluidfrom catheter 30 and through tube 28, manifold 26, tubing 90,T-connector 36 and tubing 42 to waste check valve 48 and then into wastecollection bag 52.

In a preferred embodiment of the present invention, syringe body 18,manifold 26, tube 28, catheter 30, T-connector 36, tubing 42, checkvalves 46 and 48, bags 50 and 52, and tubing 90 and 92 are alldisposable items. They must be installed in system 10 each time anangiography procedure is to be performed with a new patient. Once system10 is set up with all the disposable items installed, door 70 is closed,and syringe body 18 filled with contrast material and purged of air, theuser (typically a physician) enters into system 10 the safety parametersthat will apply to the injection of radiographic contrast material.These safety parameters typically include the maximum amount ofradiographic contrast material to be injected during any one injection,the maximum flow rate of the injection, the maximum pressure developedwithin syringe body 18, and the maximum rise time or acceleration of theinjection. To actuate an injection of contrast material, the useroperates remote control 14 by squeezing trigger 66. Within the presetsafety parameters, system 10 causes the flow rate of the injection toincrease as the force or distance of travel of trigger 66 is increased.

Typically, the user will meter the amount and rate of contrast materialinjected based upon continuous observation of the contrast outflow intothe structure being injected using fluoroscopy or other imaging methods.System 10 allows the user to tailor the contrast injections to the needsof the patient, thereby maximizing the quality of the procedure,increasing the safety, and reducing the amount of contrast materialrequired to perform the fluoroscopic examination.

FIGS. 2A-2G are diagrams illustrating fluid flow paths during sevendifferent operations of system 10. Those operational are contrast fill(FIG. 2A), air purge (FIG. 2B), patient inject (FIG. 2C), patientpressure (FIG. 2D), saline flush (FIG. 2E), aspirate waste (FIG. 2F),and medicate patient (FIG. 2G).

The contrast fill operation illustrated in FIG. 2A involves the fillingof syringe body 18 with radiographic contrast material from reservoir(contrast media supply) 22. The contrast fill operation is performedduring initial set up of system 10, and may be repeated during operationof system 10 whenever syringe body 18 is running low on radiographiccontrast material.

During initial set up of system 10, plunger 20 is initially driven toits furthest forward position adjacent closed end 76 of syringe body 18.This will expel to the atmosphere the majority of the air which islocated within syringe body 18.

Plunger 20 is then retracted, which creates a vacuum within syringe body18 which draws contrast material from reservoir 22 through check valve24 into syringe body 18 through upper port 78.

The Contrast Fill operation typically will result in some air beingdrawn into or remaining within syringe body 18. It is important, ofcourse, to prevent air from being injected into the patient throughcatheter 30. That is the purpose of the Air Purge operation shown inFIG. 2B. Also, the location of two ports at different elevations allowsfor a greater amount of safety in preventing air bubbles in theinjection.

During the Air Purge operation, plunger 20 travels forward to expeltrapped air within syringe body 18. The air, being lighter than thecontrast material, gathers near the top of syringe body 18. As plunger20 moves forward, the air is expelled from syringe body 18 through upperport 78 and one-way valve 24. In the embodiment illustrated in FIG. 2B,one-way valve 24 is a weighted one-way valve which allows flow ofradiographic contrast material from reservoir 22 to upper port 78, butwill not allow radiographic contrast material to flow in the oppositedirection from upper port 78 to reservoir 22. Valve 24 will, however,allow air to flow from port 78 to reservoir 22. As soon as radiographiccontrast material begins flowing out of syringe body 18 through upperport 78 to valve 24, valve 24 closes to prevent any further flow towardreservoir 22.

Valve 24 can also, in alternative embodiments, be a solenoid actuated ormotor driven valve operated under control of the electric circuitrywithin console 12. In either case, valve 24 is capable to withstandingthe relatively high pressures to which it will be subjected during theinject operation. Preferably, valve 24 is capable of withstanding staticfluid pressures up to about 1200 p.s.i.

FIG. 2C illustrates the Patient Inject operation. Plunger 20 travelsforward under the interactive control of the user, who is controllingtrigger 66 of remote control 14. The movement of Plunger 20 createshydraulic pressure to force contrast material out of syringe body 18through lower port 80 and through manifold 26 and high pressure tube 28into catheter 30. As shown in FIG. 2C, syringe lower port 80 and patientport 84 are connected for fluid flow during the patient injectoperation.

Manifold 26 contains a valve which controls the routing of fluidconnections between patient port 84 and either syringe bottom port 80 ortransducer/saline port 82. In one embodiment of the present invention,manifold 26 includes a spool valve which is spring biased so thatpatient port 84 is normally connected to transducer/saline port 82 (asillustrated in FIGS. 2A and 2B). When the pressure at syringe bottomport 80 builds with the movement of plunger 20 forward, the bias forceagainst the spool valve is overcome so that syringe bottom port 80 isconnected to patient port 84, and transducer/saline port 82 isdisconnected the valve within manifold 26 protects pressure transducer38 from being exposed to the high pressure generated by the patientinject operation.

The spool valve opens automatically during the patient inject operationin response to increase pressure exerted on it from the syringe lowerport 80. The spool valve closes and returns to its original positionallowing for connection of patient port 84 to transducer 38 when aslight vacuum is applied by retraction of plunger 20 at the end of eachPatient Inject operation

In an alternative embodiment, the valve within manifold 26 is anelectromechanical or motor driven valve which is actuated at appropriatetimes to connect either syringe lower port 80 or transducer/saline port82 to patient port 84. The actuator mechanism is controlled by console12. Once again in this alternative embodiment, the valve protectspressure transducer 38 from being exposed to high pressure.

FIG. 2D illustrates the Patient Pressure operation. System 10 allows forreading of the patient's blood pressure, which is monitored throughcatheter 30. Patient blood pressure can be monitored through the use ofpressure transducer 38, at any time except during the patient inject,saline flush, and waste aspirate operations. The pressure reading beingproduced by pressure transducer 38 may be normalized by manually openingstop-cock 40 and closing stop-cock 34 to expose pressure transducer 38to atmospheric pressure.

During the Saline Flush operation illustrated in. FIG. 2E, salinesolution is used to flush all of the internal lines, pressure transducerchamber 38, tube 28, and catheter 30. As shown in FIG. 2E, peristalticpump 44 is operating in a direction which causes saline solution to bedrawn from bag 50 through check valve 46 and through tubing 42 to salineport 82. Manifold 26 connects saline port 82 to patient port 84 so thatsaline solution is pumped out of patient port 84 and through tube 28 andcatheter 30.

During the Aspirate Waste operation, patient port 84 is again connectedto saline port 82. During this operation, peristaltic pump 44 isoperating in the opposite direction from its rotation during the salineflush operation. As a result, patient fluids are aspirated from patientport 84 to saline port 82 and then through tubing 42 and check valve 48into waste collection bag 52. Peristaltic pump 44 acts as a valvepinching/occluding tubing 42 and preventing back flow to/from saline andwaste containers 50 and 52 in conjunction with check valves 46 and 48.

With catheter 30 in place within the patient, it may be desirable tosupply patient medication. System 10 allows for that option by providingpatient medication port 32. As shown in FIG. 2G, when stop-cock 34 isopen, a medication source connected to port 32 will be connected topatient port 84, and thereby to catheter 30. During the medicate patientoperation, peristaltic pump 44 and plunger 20 are not moving.

FIG. 3 is an electrical block diagram of a control system that has beenused with above-described angiographic injector system. The electricalcontrol system of FIG. 3 includes a single digital computer 100, whichreceives input signals from remote control 14 and front panel controls56 through interface 102, and provides signals to display 58 to displayoperation data, alerts, status information and operator prompts. Asubsequent preferred embodiment will describe an improved electricalcontrol system; however the single computer system is being describedherein to complete the functional description of an angiographicinjector system that incorporates the components of the angiographicinjector system 10 described above.

Computer 100 controls the motion of plunger 20 through a motor drivecircuit which includes motor 104, motor amplifier 106, tachometer 108,potentiometer 110, a rectifier 112, pressure sensing load cell 114, andA/D converter 116.

Motor amplifier 106 provides a Drive 1 signal to motor 104 in responseto Control Voltage, Fwd/Rev, and/Brake signals from computer 100 and aspeed feedback signal from tachometer 108 through rectifier 112. Theoutputs of tachometer 108 and potentiometer 110 are supplied to computer100 through A/D converter 116 as Speed Monitor and Position Monitorsignals. These allow computer 100 to check motor speed, motor direction,and position (volume is a calculated value).

Pressure sensor 114 senses motor current or plunger force in order tomeasure the pressure being applied to the radiographic contrast materialwithin syringe body 18. This Pressure Monitor Signal is supplied throughA/D converter 116 and interface 102 to computer 100.

Peristaltic pump 44 is driven under the control of computer 100 throughpump motor 120, motor driver 122 and optical encoder 124. Computer 100provides Saline (Forward) and Waste (Reverse) drive signals to motordriver 122 to operate pump motor 120 in a forward direction for salineflush and a reverse direction for waste aspiration. Optical encoder 124provides the Speed Direction Monitor signal to interface 102 whichindicates both the speed and the direction of rotation of pump motor120.

FIG. 3 illustrates an embodiment of the control system in which valvemotor 130 is used to actuate valves such as one-way valve 24 and thevalve within manifold 26. In this embodiment, computer 100 controlsvalve motor 130 through motor driver 132, and monitors position througha Position Monitor feedback signal from potentiometer 134. In thisparticular embodiment, valve motor 130 is a stepper motor.

Computer 100 monitors temperature of the contrast material based upon aTemp Monitor signal from temperature sensor 140. Temperature sensor 140is preferably positioned near syringe body 18. If the temperature beingsensed by temperature sensor 140 is too high, computer 100 will disableoperation motor 104 to discontinue patient injection. If the temperatureis too low, computer 100 provides a/Temp Enable drive signal to heaterdrive 150, which energizes heater 152. In one preferred embodiment,heater 152 is a resistive film heater which is positioned within syringeholder 116 adjacent to syringe body 18.

Computer 100 also receives feedback signals from contrast bottle sensor160, forward limit sensor 162, reverse limit sensor 164, syringe missingsensor 166, chamber open sensor 168, no contrast bubble detector 170,and air in line bubble detector 172.

Contrast bottle sensor 160 is a miniature switch located withinreservoir holder 72. The state of the Contrast Bottle Present signalfrom sensor 160 indicates whether a reservoir 22 is in position withinholder 72. If reservoir 22 is not present, computer 100 will disable thefill operation.

Forward limit and reverse limit sensors 162 and 164 sense the end limitpositions of plunger 20. When plunger 20 reaches its forward limitposition, no further forward movement of plunger 20 is permitted.Similarly, when reverse limit sensor 164 indicates that plunger 20 hasreached its reverse limit position, no further reverse movements arepermitted.

Syringe missing sensor 166 is a miniature switch or infraredemitter/detector which indicates when syringe body 18 is not in positionwithin syringe holder 16. If syringe body 18 is not in position, allmovement functions are disabled except that plunger 20 can move to itsreverse limit position (i.e., return to zero).

Chamber open sensor 168 is a miniature switch or infraredemitter/detector which senses when door 70 of syringe holder 16 is open.When the signal from sensor 168 indicates that door 70 is open, allmovement functions are disabled. Only when door 70 is closed and lockedmay any movement be allowed. When door 70 is indicated as closed andsensor 166 indicates the syringe body 18 is in position, other normalfunctions of the system 10 can proceed.

Bubble detector 170 is positioned between reservoir 22 and top port 78,and is preferably an infrared emitter/detector which senses air bubbles.If an air bubble is sensed in the flow path between reservoir 22 and topport 78 during a fill operation, the fill operation is disabled until anew reservoir is connected.

Bubble detector 172 is positioned to sense air bubbles in high pressureline 28. It is preferably an infrared emitter/detector type of bubbledetector. Any air bubble which is sensed in high pressure line 28results in the disabling of all fluid push out functions, whether thefluid is saline solution from peristaltic pump 44 or contrast materialfrom syringe body 18.

The control system of FIG. 3 also includes the capability to provide acontrol signal to x-ray equipment through relay 180 which is controlledby computer 100. In addition, computer 100 receives data from bloodpressure transducer 38 and from an electrocardiograph (ECG) system,which is separate from injector system 10. The Pressure and ECG signalsare received through signal conditioners and A/D converter 190, and aretransferred to computer 100. The ECG signal is used by computer 100 inone preferred embodiment, to synchronize operation of motor 104 (andthus the Patient Inject operation) with heart beats.

Blood flow to the heart occurs predominantly in diastole (when the heartis between contractions). Continuous injection of contrast materialresults in spillage of the contrast material into the aorta duringsystole (during contraction). By injecting primarily during diastole,contrast dosage can be reduced without impairing the completeness of thecontrast injection into the coronary artery.

In a preferred embodiment, the injection of radiographic contrastmaterial is synchronized to the coronary artery blood flow. The timeperiods of systole and diastole are determined using anelectrocardiographic (ECG) electrical signal, arterial blood pressurewaveform analysis, or other timing based on the heart rate. Bycontrolling speed of motor 104, speed and therefore movement of plunger20, the injection of contrast material is interrupted during the periodof systole, which reduces or stops contrast injection during this time.In combination with remote control 14, the operator can vary the rate ofcontrast injection into the coronary artery while computer 100automatically pulses the contrast injection to the cardiac cycle.

The inertial forces of the moving contrast material and expansion of thecontainers and tubing holding the contrast material and transmitting itto the patient can cause a phase lag between movement of plunger 20within syringe body 18 and movement of contrast material out of catheter30 into the patient. To adjust to the phase lag between the plunger 20movement and contrast expulsion into the patient, a variable time offsetcan be entered through control panel 54 such that the timing of thecardiac cycle can be offset by a selected time. Since the magnitude ofthe phase lag may be dependent on the frequency of the heart rate, analgorithm within computer 100 continuously and automatically adjusts themagnitude of the time offset, based on the instantaneous heart rateduring the injection of contrast material.

FIG. 4 shows one embodiment of control panel 54 which illustrates thefront panel control switches 56 and display 58 of one embodiment of thepresent invention. Front panel control switches 56 include SetUp/Fill/End switch 200, Purge switch 202, Aspirate switch 204, Salineswitch 206, Enable OK switch 208, Injection Volume Limit switches 210 aand 210 b, Injection Flow Rate Limit switches 212 a and 212 b, InjectionPressure Limit switches 214 a and 214 b, Rise Time switches 216 a and216 b OK switch 218, Injection Range Toggle switch 220, Large InjectionOK switch 222, and Stop switch 224.

Set Up/Fill/End switch 200 is a momentary push button switch. When it isfirst activated, the user will be notified to place syringe 18 insyringe holder 16. When syringe 18 has been placed in syringe holder 16(which is indicated to computer 100 by sensor 166), the user will beinstructed to close and lock the chamber (i.e., to close door 70).Plunger 20 is moved to its full forward position expelling all airwithin the syringe. Display 58 then indicates to the operator thatcontrast reservoir 22 should be connected. Once contrast reservoir 22has been put in place, the operator is requested to depress OK switch218, at which time plunger 20 will retract at a set rate (preferablycorresponding to a flow rate of 10 ml per second) to the maximum syringevolume. If the real speed (as indicated by feedback to computer 100 fromA/D converter 116) is greater than the set speed, system 10 will stop.

Once plunger 20 is at its rearward most position, motor 104 is actuatedto move plunger 20 forward to purge all air bubbles. Pressure sensor 114provides an indication of when one-way valve 24 is closed and pressureis beginning to build up within syringe body 18. Once the purge iscompleted, the total volume injected and the number of injectionscounter is reset.

The actuation of switch 200 also allows for Ml retraction anddisengagement of plunger 20 from syringe body 18.

Purge switch 202 is a protected momentary push button switch. Whenactivated, Purge switch 202 causes plunger 20 to move forward to expelair through top port 78. The forward movement of plunger 20 is limitedand stopped when a predetermined pressure within syringe 18 is reached.This is sensed by pressure sensor 114. The purge operation which isinitiated by Purge switch 202 will expel air within syringe 20. The usermay also use Purge switch 202 to purge fluid through patient port 84 bydepressing and holding Purge switch 202 continuously on.

Aspirate switch 204 is a momentary push button switch which causescomputer 100 to activate pump motor 120 of peristaltic pump 44. Pumpmotor 120 is operated to aspirate catheter 30 at a set speed, with theaspirated fluid being collected in waste bag 52. All other motionfunctions are disengaged during aspiration. If the real speed of motor120 is greater than a set speed, computer 100 will stop motor 120.

Saline switch 206 is an alternate action switch. Pump motor 120 isactivated in response to Saline switch 206 being pushed on, and salinesolution from bag 50 is introduced into manifold 26 and catheter 30 at aset speed. If Saline switch 206 is not pushed a second time to stop theflow of saline solution within 10 seconds, computer 100 automaticallystops pump motor 120. If a time-out is reached, Saline switch 206 mustbe reset to its original state prior to initiating any further actions.

Enable OK switch 208 is a momentary push button switch. After the systemhas detected a disabling function at the end of an injection other thana limit, Enable OK switch 208 must be activated prior to activating OKswitch 218 and initiating any further function.

Injection Volume Limit keys 210 a and 210 b are pushed to eitherincrease or decrease the maximum injection volume that the system willinject during any one injection. Key 210 a causes an increase in themaximum volume value, and key 210 b causes a decrease. Once the maximuminjection volume limit has been set, if the measured volume reaches theset value, computer 100 will stop motor 104 and will not restart untilOK switch 218 has been depressed. If a large injection (i.e., greaterthan 10 ml) has been selected, OK switch 218 and Large Injection OKswitch 220 must both be reset prior to initiating the large injection.

Injection Flow Rate Limit keys 212 a and 212 b allow the physician toselect the maximum flow rate that the system can reach during any oneinjection. If the measured rate (which is determined by the feedbacksignals from tachometer 108 and potentiometer 110) reaches the setvalue, computer 100 will control motor 104 to limit the flow rate to theset value.

Injection Pressure Limit keys 214 a and 214 b allow the physician toselect the maximum pressure that the system can reach during any oneinjection. If the measured pressure, as determined by pressure sensor114, reaches the set value, computer 100 will control motor 104 to limitthe pressure to the injection pressure limit. The injection rate willalso be limited as a result.

Rise Time keys 216 a and 216 b allow the physician to select the risetime that the system will allow while changing flow rate during any oneinjection. Computer 100 controls motor 104 to limit the rise time to theset value.

In alternative embodiments, keys 210 a-210 b, 212 a-212 b, 214 a-214 b,and 216 a-216 b can be replaced by other devices for selecting numericalvalues. These include selector dials, numerical keypads, and touchscreens.

OK switch 218 is a momentary push button switch which resets functionsand hardware sensors. In response to OK switch 218 being activated,computer 100 controls display 58 to ask the operator to acknowledge thatthe correct function has been selected. Activation of OK switch 218causes the status to be set to Ready.

Injection Range switch 220 is a toggle switch. Depending on whetherswitch 220 is in the “small” or “large” position, it selects either ahigh or a low injection volume range for the next injection.

Large Injection OK switch 222 is a momentary push button switch. Whenthe large injection range has been selected by injection range switch220, the Large Injection OK button 222 must be activated to enable OKswitch 218. OK switch 218 must be activated prior to each injection. Onlarge volume injections, the user is required to verify the volumeselected by activating first Large Injection OK switch 222 and then OKswitch 218.

Stop switch 224 is a momentary push button switch. When stop switch 224is pushed, it disables all functions. Display 58 remains active.

Display panel 58 includes Set-Up display 250, Status display 252, Alertsdisplay 254, Limits display 256, total number of injections display 260,total volume injection display 262, flow rate display 264, injectionvolume display 266, injection volume limit display 268, injection ratelimit display 270, pressure limit display 272, rise time minimum display274, large injection display 276, and real time clock display 278.

Set-Up display 250 contains a series of messages which are displayed asthe operator goes through the set up procedure. The display of messagesin set up display 250 are initiated by the actuation of set up switch200 as described previously.

Status display 252 provides a flashing indication of one of severaldifferent operating conditions. In the embodiment shown in FIG. 4, thesestatus conditions which can be displayed include “Ready”, “Set-Up”,“Injecting”, “Filling”, “Flushing”, and “Aspirating”.

Alerts display 254 and Limits display 256 notify the operator ofconditions in which system 10 has encountered a critical controlparameter and will disable operation, or has reached an upper or lowerlimit and will continue to function in a limited fashion, or has reachedan upper or lower limit and will continue to operate.

Total number of injections display 260 displays the total number ofinjections (cumulative) given for the current patient case. Thecumulative total volume injected during the current patient case isdisplayed by total volume display 262.

Displays 264 and 266 provide information on the current or lastinjection. Display 264 shows digital value of the real time flow rate tothe patient during injection. Once the injection is completed, the valuedisplayed on display 264 represents the peak flow rate reached duringthat injection. Display 266 shows the digital value of the volumeinjected during the most recent injection.

Display 268 displays the digital value of the maximum injection volumeselected by operation of switches 210 a and 210 b. Similarly, display270 shows the digital value of the maximum flow rate that the systemwill allow, as selected by switches 212 a and 212 b.

Display 272 shows the digital value of the maximum pressure that thesystem will allow to be developed in syringe 18. The pressure limit isselected by switches 214 a and 214 b.

Display 274 displays the minimum rise time that the system will allowwhile changing flow rate. The minimum rise time is selected throughswitches 216 a and 216 b.

Large injection display 276 provides a clear indication when the largeinjection scale has been selected by the operator.

Real-time clock display 278 shows the current time in hours, minutes,and seconds.

FIGS. 5A and 5B show one embodiment of a remote control 14 whichincludes main housing 300, which is designed to conform to the usershand. Trigger 66 is movable with respect to housing 300, and theposition of trigger 66 generates a command signal which is a function oftrigger position. In one embodiment, trigger 66 is linked to apotentiometer within housing 300. The command signal controls theinjunction flow rate or speed. The flow rate is directly proportional totrigger position.

Reset switch 62 is a momentary push button switch whose function isidentical to that of OK switch 218. Alternatively, Reset switch 62 mayalso be labeled “OK”.

Saline switch 64 on remote control 14 is an alternate action push buttonswitch which is pushed to turn on and pushed again to turn off. Thefunction of Saline switch 62 is the same as that of Saline switch 206 onfront panel 54.

As illustrated in another embodiment of the present invention, analternative remote control 14′ in the form of a foot pedal is usedinstead of the hand held remote control 14 illustrated in FIG. 1 and inFIGS. 5A and 5B. Foot pedal remote control 14′ includes foot operatedspeed pedal or trigger 66′ for providing a command signal, as well asReset or OK switch 62′ and Saline switch 64′. Covers 310 and 312 protectswitches 62′ and 64′ so that they can only be actuated by hand and notaccidentally by foot. Foot pedal remote control 14′ is connected toconsole 12 by cable 60′, but could alternatively be connected by awireless link.

FIGS. 7A-7D and FIGS. 8A-8C illustrate the construction and operation ofone way valve 24 and manifold 26 during Contrast Fill, Air Purge andPatient Injection operation.

FIGS. 7A and 8A illustrate one way or check valve 24, manifold 26,syringe body 18, and plunger 20 during a Contrast Fill operation. Inletcheck valve of one way valve 24 includes weighted ball 350 which ispositioned at its lower seated position within valve chamber 352 inFIGS. 7A and 7B. Contrast material is being drawn into syringe body 18by the rearward movement of plunger 20. The contrast material flowsthrough passages 354 around ball 350 and into upper port 78.

Manifold 26 contains spring loaded spool valve 360, which includes spoolbody 362, shaft 364, O-rings 366, 368 and 370, bias spring 372, andretainer 374. As shown in FIG. 7A, during the Contrast Fill operation,bias spring 372 urges spool body 362 to its right-most position towardsyringe body 18. In this position, spool body 362 blocks lower port 80of syringe body 18 while connecting transducer saline port 82 to patientport 84 through diagonal passage 376. O-rings 366 and 368 on the onehand, and O-ring 370 on the other hand, are positioned on the oppositesides of diagonal passage 376 to provide a fluid seal.

FIGS. 7B and 8B illustrate the Air Purge operation. Syringe body 18 hasbeen filled with contrast fluid, but also contains trapped air. Plunger20 is driven forward to force the air out of syringe body 18 throughupper port 78 and through check valve 24. The force of the air may causea slight lifting of ball 350 in check valve 20. Ball 350, however, issufficiently heavy that the air being forced out of syringe body 18 andback toward reservoir 22 cannot lift ball 350 into its uppermost seatedposition where it would block the flow of air out of syringe body 18.

During the Air Purge operation, spool valve 360 is in the same positionas in FIG. 7A. Diagonal passage 376 connects transducer saline port 82with patient port 84. As a result pressure monitoring by pressuretransducer 38 can be performed during the Air Purge (as well as theContrast Fill) operation.

FIGS. 7C and 8C illustrate the state of manifold 26 and check valve 24at the end of the Air Purge operation and at the beginning of a PatientInject operation.

In FIG. 7C, all air has been expelled from syringe body 18. Ball 350 mayfloat on the radiographic contrast material, so that when all air hasbeen removed and the radiographic contrast material begins to flow outof syringe body 18 and through upper port 78 to valve chamber 352, ball350 is moved upwards to its upper seated position. Ball 350 blocks anycontinued upward flow of radiographic contrast material, as isillustrated in FIGS. 7C and 8C.

In the state which is illustrated in FIG. 7C, the pressure withinsyringe body 18, and specifically the pressure in lower port 80 has notyet reached a level at which the bias force of spring 372 has beenovercome. As a result, spool body 362 has not yet moved to the left anddiagonal passage 376 continues to connect transducer saline port 82 withpatient port 84.

FIG. 7D illustrates the patient inject operation. Plunger 20 is movingforward, and inlet check valve 24 is closed. The pressure at lower port80 has become sufficiently high to overcome the bias force of spring372. Spool body 362 has been driven to the left so that lower port 80 isconnected to patient port 84. At the same time spool body 362 blockstransducer/saline port 82.

By virtue of the operation of spool valve 360, the high pressuregenerated by movement of plunger 20 and syringe body 18 is directlyconnected to patient port 84, while saline port 82 and pressuretransducer 38 are protected from the high pressure. The pressure toactuate may be variable and determined after manufacture by increasingor decreasing the syringe preload.

Those skilled in the art will appreciated that other configurations ofthe general angiographic injector system 10 can be configured. Forexample, the alternative syringe and mounting system portions of thereferenced angiographic injector system described in U.S. Pat. No.6,099,502, entitled “Dual Port Syringe” (herein incorporated byreference), could be employed to replace and/or modify those previouslydescribed. Further, those skilled in the art will recognize otherimprovements such as to the manifold portion of the assembly, as forexample described in U.S. Pat. No. 6,221,045, entitled “AngiographicInjector System with Automatic High/Low Pressure Switching” (hereinincorporated by reference), could be employed, as well as otherconfigurations of the remote control 14. Several alternativeconfigurations of the remote control assembly are described in thisreferenced application and in U.S. Pat. No. 5,916,165, entitled“Pneumatic Controller- and Method” and U.S. Pat. No. D404,717, entitled“Hand-Held Pneumatic Control Device, all of which are hereinincorporated by reference.

An alternative embodiment configuration of the angiographic injectorsystem of the preceding figures is generally indicated at 10′ in FIGS. 9a and 9 b. In the embodiment illustrated in FIG. 9, the physicallocations of some of the components of the angiographic injector system10 have been rearranged for facilitating use of the system. For example,the user interface 54, the control switches 56 and the display 58 of thefirst described embodiment have been consolidated into a single controlpanel 400. In the second embodiment illustrated, the control panel 400mounts to the console or injector head 12′ on a swivel base that may bedisconnected and reconnected by the user for optimal placement. Amechanical diagrammatic chart of the FIG. 9 configuration is illustratedin FIG. 10. Referring to FIGS. 9 and 10, the Power supply 59′ circuitsare illustrated as being mechanically mounted separate from the console12′. The console and power supply are mounted to a cart, generallyindicated at 402 which includes wheels for easy movement and which ispreferably designed to provide stability and deter tipping when used inits intended method. The cart enables the console and power supplyassemblies to be rapidly attached and detached for allowing docking ofthe console and power supply to a bed or other stationary deviceequipped with a mating connection device. Referring to FIG. 10, the handcontroller 14′ is illustrated as being operatively connected to thecontrol panel 400, and the peristaltic pump assembly 44′ is indicated asbeing mechanically mounted to the console 12′. The assembly for holdingthe syringe and related components that have been previously describedwith regard to the first embodiment of the invention are generallyindicated by the functional block entitled “mounting chamber” 404. Thosecomponents previously described and referred to as “disposable” items(i.e.: the syringe, the piston within the syringe body, the contrastvalve, the patient manifold, the contrast spike and the patient bloodpressure port) are generally designated by the functional block 406.

An electrical functional block diagram of a second preferred controlconfiguration for the angiographic injector system 10′ is illustrated inFIG. 11. The multiple figures (FIG. 11 a and FIG. 11 b) collectivelycomprise the electrical control network of the angiographic injectorsystem 10′. For ease of description of the FIG. 11 network, numberspreviously used for comparable electrical components of the firstembodiment will not necessarily be duplicated in the description ofsimilarly functioning electrical components of FIG. 11. Referring toFIG. 11, the control system includes two separate computer systems, eachhaving intelligence for monitoring and controlling functions of theinjector system. As with the prior embodiment, the computer systemgenerally receives input signals from the control panel 400 and providessignals to display data, alerts, status information and operatorprompts. In the preferred embodiment, the computer system comprises twomicro-computers. A PC processor, generally indicated at 410 acts as themaster processor of the control system, and an embedded processor,generally indicated at 412, acts as the slave processor. In general, themaster processor instructs the embedded processor to perform commands,but both processors monitor the actions taken. Both processors serve asindependent monitors of action, for safety. Key functions such as theinjector motor movement and peristaltic motor movement are monitored byboth micro-computers. In the preferred embodiment, the PC processor 410has a 386 DOS central processing unit, and the embedded core processor412 has an HC16 bit central processing unit. It will be appreciated thatother types of microprocessors can be used within the spirit and intentof this invention.

Referring to FIG. 11, it will be noted that PC processor 410communicates with electrical components throughout the system by meansof a first communication bus 414, and the embedded core processor 412communicates with electrical circuits throughout the system by means ofa second communication bus 416. The two processors communicate with oneanother by means of their respective buses and a pair of communicationregisters generally indicated at 417 and 418. General “watch dog/powerfail/reset” functions are indicated by the functional block 419, and ECGacquired information can be collected on a first-in first-out basis bythe functional block 420 for processing by both microprocessors. Ingeneral, the type of communication between the various electricalfunctional blocks of the system and the two buses 414 and 416 asindicated by the individual signal flow paths of FIG. 11 which areassociated with the respective electrical functional blocks and by thesignal flow notations within those signal flow paths.

Referring to FIG. 11, the various electrical and sensing functionsassociated with the mounting chamber 404 include: a sensor entitled“chamber closed” (422) that indicates when the front loading chamberdoor used to load the disposable syringe into the mounting chamber isclosed; a contrast bottle sensor indicated by “contrast empty” (423)which is located within the bottle holder and indicates whether fluid ispresent in the bottle; two valve sensors, indicated as “upper & lowervalve sensors” (424) that are used by the computer to determine thestate of the patient manifold valve and contrast valve; anelectroluminescent back light, indicated by “EL backlight” (425) whichfacilitates manual bubble detection within the syringe and disposableitems; a heating element, indicated by “contrast heater” (426) locatedinside the syringe holder adjacent to the syringe body; a pair oftemperature sensors, indicated by “RTD Temp Sensor” (427) positionednear the syringe body for providing signals to control the contrastheater for maintaining the contrast material at a relatively constanttemperature; and an air column detection sensor, indicated by “bubbledetect” (428) positioned to sense air in the high pressure line whichmonitors fluid that is pumped to the patient for any bubbles or aircolumns. As indicated in FIG. 11, except for the EL backlight 425, eachof the sensors in the mounting chamber communicate with both of theprocessors.

In general, the control panel 400 includes an arm light 430, a speaker431, a touch screen 432, a display 433, and an emergency switch 434. Thearm light 430 is lit when the injector is ready to perform an injection.The speaker 431 is an optional feature which can provide audibleinterface communication with the user. The display 433 is in thepreferred embodiment a liquid crystal (LCD) panel which is used todisplay the operational state of the system. The touch screen 432 isoverlayed on the LCD panel and is used by the user to control thesystem, as will be described in more detail hereinafter. All of thefunctions of the control panel communicate directly with the PCprocessor 410. The emergency switch 434 communicates directly with bothof the communication buses 414 and 416 as well as with cutoff relays andthe injector motor solid state relay hereinafter described.

The hand control functional block 14′ includes the circuit functions ofthe remote hand control unit. As previously described, the handcontroller is a device used to control the angiographic injector pump ina manner such that when actuated by a user, outputs an electrical signalwhich is proportional to the displacement of the hand controlled device.The controller is a passive electromechanical device that communicateswith both of the microprocessors as indicated in FIG. 11. The handcontroller contains a pair of scaled on-contact sensors that canremotely determine position of an object and which are used to determinethe active travel distance and placement of the hand movable portion ofthe controller. The sensors are indicated by the two functional blocksindicated as “analog Hall effect” (440) and “digital Hall effectsqueeze” (441). The saline reset function is indicated by “saline resetbutton” (442), and the functional block indicated as “control type andconnected” (443) provides for a setting indication through the handcontroller to the microprocessors as to whether the system is being usedto perform a “fixed rate” or “variable rate” injection. Under thevariable rate mode of operation, the operator is allowed to vary theinstantaneous injection rate by means of the hand controller up to apredetermined maximum flow rate. In the fixed mode of operation, whenthe operator squeezes the hand controller actuator, the control systemwill respond by simply injecting the contrast material at thepredetermined fixed rate that has been entered into the control systemprior to the injection procedure.

The peristaltic pump 44′ is driven under the control of themicroprocessors through a pump motor and motor driver. The motor driver,generally indicated by the “PWM control circuitry” (450) provides apulse width modulated control signal to the peristaltic pump motor. Thecomputer provides both forward (Saline) and reverse (Waste) drivesignals to the motor driver to operate the pump motor in a forwarddirection for a saline flush and in a reverse direction for wasteaspiration. The peristaltic pump of the preferred embodiment includes an“overspeed overtorque” sensor 451 and “cutoff relays” 452. Theoverspeed/overtorque sensors 451 provide feedback signals to themicroprocessors for accurately controlling the speed of the peristalticpump by way of the pump drive circuits 450. The cutoff relays 452 can beactivated by either of the microprocessors or by the emergency stopswitch 434.

The injector motor 460 is operatively connected to move the piston orwiper within the syringe and is controlled by a “motor controller”amplifier (461). In the preferred embodiment, the motor driver 461 is anoff-the-shelf servo amplifier which can be accurately controlled bymeans of a nested loop control configuration, hereinafter described. Ingeneral, the motor amplifier provides a drive signal to the motor inresponse to a control voltage. Forward, reverse and break signals comefrom the computer, and a speed feedback signal from an optical encoderis used to control the speed. Monitoring of the motor status isgenerally indicated by the functional block entitled “motor statusoverspeed/overtorque” (462) and an independent optical encoder sensorfor sensing the motor speed and position, indicated by the “encoder”functional block (463). A potentiometer is used to provide a back-upsignal to the embedded microprocessor indicating the absolute “position”of the motor. The potentiometer is indicated in the block diagram as the“absolute position pot.” functional block (464). The outputs of theoptical encoder and potentiometer are supplied to the processors asspeed monitor and position monitor signals and allow the computers tocheck motor speed, motor direction and position. A pair of forward andreverse limit sensors sense the end limit positions of the syringepiston and are indicated by the functional block entitled “F/R limitswitches” (465). When the piston reaches its forward limit position, nofurther forward movement is permitted. Similarly, when the reverse limitsensor indicates that the piston has reached its reverse limit position,no further reverse movements are permitted. The injector motor controlalso includes a solid state relay (470) for disabling the injector motorunder command from either of the processors or the emergency switch 434.

The power supply 59′ provides all electrical power to the system andincludes an externally selectable voltage range switch 59 a′ enablingselection of connection of the power supply to either 110-120 volts ACor 220-240 volts AC. In the preferred embodiment, the line voltageoperating frequency must bc between 47 and 63 Hz, and the line voltagemust be capable of carrying ten amps of current. The power supplyfurther includes a power indicator light 59 b′ an on/off switch 59 c′and a cable connector 59 d′ providing a connector for a cable leading tothe circuits within the chassis 12′.

A more detailed electrical functional block circuit network for apreferred nested control loop configuration for control of the injectormotor 460 is illustrated in FIG. 12. Referring thereto, the injectormotor 460 is in the preferred embodiment, a brushless DC motorcontrolled by the servo amplifier network circuit 461. In the preferredembodiment, the servo amplifier network 461 is a BE30A Series PWMBrushless Servo Amplifier model BE25A20 designated to drive a brushlessDC motor at a high switching frequency. In the preferred embodiment, theservo amplifier uses a quadrature encoder feedback input signal forvelocity control. The servo amplifier has an output drive port generallyindicated at 461 a, a feedback signal input port 461 b, a speed controlsignal input port 461 c and a pair of analog output signal ports 461 dand, 461 e respectively. The output port 461 d carries a voltage signaldeveloped within the servo amplifier that is proportional to thepressure or torque of the motor 460, and provides a signal to an outputfeedback line referred to as the “Analog Current” line. The output port461 e carries a voltage signal developed within the servo amplifier thatis proportional to the speed of the motor 460, and provides a signal tothe line indicated as “Analog Speed”. An optical quadrature encoder (notillustrated in FIG. 12) is operatively connected to the output drive ofthe injector motor 460 (and indicated at 463 in FIG. 11), provides apulse train feedback signal back to the feedback input port 461 b of theservo amplifier 461 to provide accurate speed control of the motor 460through the servo amplifier 461. This loop is referred to as the firstloop or the “Servo Loop” in the figure. In the preferred embodiment, theservo amplifier 461 is an off-the-shelf amplifier that provides veryaccurate control of the speed of the injector motor 460 through thisstandard Servo Loop configuration and requires little further control.The quadrature encoder signal is also fed back through a signalconditioning Decode Circuit indicated at 472 to a pair of counters 473and 474 which respectively provide cumulative count signals to theembedded processor 412 and the PC processor 410 respectively. The AnalogCurrent and Analog Speed signals from the output ports 461 d and 461 erespectively of the servo amplifier 461 are directly fed as inputsignals to the embedded processor 412 and are respectively applied tofirst signal inputs of comparators 462 a and 462 b of the “motor statusoverspeed overtorque” functional block 462. The reference signal inputsfor the comparators 462 a and 462 b are connected to receive inputsignals from the PC processor 410 corresponding to “torque reference”and “speed reference” input signals.

The comparators 462 a and 462 b respectively compare the feedbacksignals received from the servo amplifier 461 with the reference voltagesignals received from the PC processor 410 and provide signal outputsrepresenting “overtorque” and “overspeed” respectively to both theembedded processor 412 and the PC processor 410, as indicated in FIG.12.

During an injection procedure, the master PC processor 410 instructs theembedded processor 412 to perform the injection. As part of thiscommand, the embedded processor is told by the PC processor what thedesired flow rate and maximum pressure allowed conditions are.Immediately prior to the PC processor issuing the injection command, itsets reference voltage values in the two comparators 462 a and 462 b,one being representative of the maximum flow rate the embedded processoris allowed to achieve and the other representing the maximum allowablepressure. During the injection, the “Analog Current” and the “AnalogSpeed” feedback signals from the servo amplifier 461 are fed back to thecomparators 462 a and 462 b. If either of these feedback signal voltagesexceed the respective reference voltages of the comparators, anappropriate output signal is provided by the triggered comparator, backto both of the processors. If either processor receives one or bothsignals from the comparators, that processor will cut power to theinjector motor 460, immediately stopping the injection.

During an injection, the embedded processor 412 uses the digital encoder463 to determine the current position of the ram or syringe piston. Inthe preferred embodiment, for each millimeter of contrast materialinjected 1,317 counts are received from the encoder 463. As the pistonmoves during an injection, the embedded processor looks at the currentposition of the ram or piston every ten milliseconds. The embeddedprocessor then calculates the theoretical position of the ram based on asimple trapezoidal type move. If the current position is more than apredetermined number of millimeters different than the actual position,the injection is stopped and error is reported.

The potentiometer 464 which provides the “Analog Position” signal isused in a similar fashion, however its tolerance is higher. During ramor piston movement calibration, the system calculates a constant that isrepresentative of the number of ohms per millimeter of movement. Duringthe injection, the embedded processor uses the same theoreticaltrapezoidal move to determine the theoretical position of the piston. Aswith the digital encoder process, if the current position of the ram ismore than a predetermined number of ohms different than the actualanalog position reading, the injection is stopped and an error isreported.

Accordingly, a nested loop control network is established wherein theprimary direct Servo feedback loop control of the motor 460 issupplemented by the “Error Loop” control provided through the encodersignal which is fed back through the decoder circuitry 472 and counter473 and embedded processor 412 back to the signal input terminal 461 cof the servo amplifier 461. The first or “servo loop” is a standardvelocity control loop that uses proportional integration; whereas theouter “error loop” is a position control loop which simply periodicallychecks on the servo loop control to ensure that the servo loop isaccurately controlling the motor speed. The potentiometer which isoperatively connected to the gear train output of the motor 460 is anabsolute position sensor that simply acts as a back-up to the encoderloop. Similarly, the encoder feedback to the PC processor 410 throughcounter 474 acts as a redundant back-up to the primary error loopcontrol through embedded processor 412, should the processor 412 fail tooperate in its intended manner in providing speed correction signalsthrough the secondary “error loop”.

As briefly described above, the availability of multiple processorsprovides the capability of true multi-redundancy sensing usingintelligence in both sensing circuits. In addition, the dual or multipleprocessor feature provides the capability for redundant control andmonitoring safety features of key functions of the system such asinjection motor movement and peristaltic motor movement. Both of theseconditions are actively monitored by both microprocessors as describedabove, and as indicated in FIGS. 11 and 12. For example, an “overspeedsafety circuit” for the injection motor is provided by the quadratureencoder 463 feeding signals through the decode circuitry 472 and thepair of counters 473 and 474 to the two processors. The use of twoindependent processors for receiving the encoder information acts as asafety circuit for sensing the flow rate, since both the embedded and PCprocessors count pulses to determine the injection flow rate. As statedabove, the individual counts are accumulated over a specified timeinterval and the average speed is computed. The safety feature isprovided by the fact that either processor may independently shut downthe injector motor based on its own decision making capability, in theevent of an overspeed condition. Such redundant sensing path dualprocessor control allows for safety monitoring in the event of a singlecomponent failure.

Similarly, an “over volume safety circuit” is provided by the samehardware used to provide the over-speed safety circuit. The pulsesprovided through counters 473 and 474 from the encoder to the embeddedand PC processors allow both processors to independently count pulses todetermine injection volume. Either processor may independent shut downthe injector motor in the event of an over-volume condition.

A further dual safety feature, which does not require multipleprocessors, is provided by the “analog position” signal received fromthe potentiometer 464 which allows the embedded processor to check thevolume by reading the change in the analog voltage output from thepotentiometer. By providing the potentiometer as a back-up for thequadrature encoder, further dual redundancy safety is provided forsensing the injection volume.

Dual redundant motor safety circuits are provided as previouslydescribed for the injector motor “over current” and “overspeed”conditions. These circuits were previously described with respect tocomparators 462 a and 462 b. The comparator 462 a uses the “analogcurrent” feedback signal from the servo amplifier 461 to provide dualinput signals to both the embedded and PC processors to provide dualprocessor current measurement safety circuit sensing. Similarly,comparator 462 b applies dual input signals to both of the processors asthe result of the “analog speed” signal from the servo amplifier 461 toprovide dual redundant sensing of the injector motor speed.

Similar safety circuits are provided for control of the peristaltic pump44′. As indicated in FIG. 11, the peristaltic pump also includes anoverspeed/overtorque network 451. In the preferred embodiment, theperistaltic pump 44′ is not a brushless motor like the injection motor,and receives a pulse width modulated input signal from the PWM controlcircuitry 450. Pump motor 44′ develops a back EMF that can be sensed andused as a feedback signal along with the output current from the motordriver circuit 450. An electrical block diagram representation of theperistaltic pump safety circuits is illustrated in more detail in FIG.13. Referring thereto, the PC and embedded processors are indicated at410 and 412 respectively. The safety circuit illustrated in FIG. 13 isvirtually identical to that used for sensing the speed, and current ofthe injector motor. A pair of comparators 451 a and 451 b of theoverspeed/overtorque network 451 are used in manner similar to thecomparators 462 a and 462 b previously described with respect to thesafety circuits of the injector motor. The comparator 451 a provides anovertorque output signal to both of the processors, and the comparator451 b provides an overspeed input signal to both of the processors.Comparator 451 receives a torque reference voltage signal from the PCprocessor 410 and the comparator 451 b receives a speed referencevoltage signal from the processor 410. The comparator 451 a monitors acurrent output signal from motor driver network 450 and provides anoutput signal whenever the monitored current output signal exceeds thetorque reference signal provided from processor 410. The comparator 451b monitors a back EMF signal from motor 44′ and provides an outputsignal whenever the back EMF signal exceeds the speed reference voltagesignal applied by processor 410. The embedded processor 412 provides theprimary drive control signal to the motor driver 450.

In the embodiment of the invention illustrated in FIG. 9, alloperator/user interface with the system is performed through the controlpanel, except for turning on the power supply and activation of theemergency stop switch. Communication with the processor or processors ofthe system is performed through switches on the touch screen 432overlying the display 433. The computer generates various screens on thedisplay, with appropriate simulated switch indicators that align withtouch pads on the touch screen, which enable the operator to communicatewith the microprocessor(s) through the touch screen. When power isinitialized to the system, the control panel display will communicate tothe user that the system is performing self diagnostic tests. Followingthe diagnostic and calibration tests, the display will illustratevarious set-up windows providing a series of instructions for theoperator that will guide the operator through the step-by-step set-upprocedure, generally including syringe loading, locking and filling,disposable connections, and flushing.

Sample screens that are generated by the PC processor and which aredisplayed to the user for the power-up, calibration and self diagnosticfunctions are illustrated in FIGS. 14-17. Referring thereto, the initialPower-up screen is illustrated in FIG. 14. This screen remains visiblewhile the system runs in an internal diagnostic check to make sure allfunctions are working properly. The system will then automatically beginset-up and calibration. The screen of FIG. 15 will appear as the syringeram moves to a back position, after which the screen of FIG. 16 will bedisplayed which instructs the operator how to load the syringe assembly.Upon completion of the syringe loading sequence, the operator pushes the“Done” pad on the touch screen of FIG. 16. The system is now ready tobegin the “set-up” procedure, and displays the screen of FIG. 17 whilethe syringe ram is moved to its forward position.

The “set-up” instructions begin with the screen of FIG. 18. Referringthereto, the operator is instructed in a step-by-step manner as to howto load the tubing assembly portion of the system. When the operator hascompleted the steps identified in FIG. 18, he activates the touch screenby pushing the “Done” switch, and proceeds to the steps indicated on thescreen of FIG. 19. The screen of FIG. 19 includes flushing operations ofthe pressure dome, manifold and fluid lines. When these steps have beencompleted and the “Done” switch has been activated, the set-upinstruction screen of FIG. 20 will be displayed. Screen 20 providesinstructions for attaching the pressure transducer and pump assembliesof the system. Upon completion of the FIG. 20 screen items andactivation of the “Done” switch, the set-up instructions of the screenof FIG. 21 will bc displayed. The steps of FIG. 21 complete the set-upinstructions, and when the operator activates the “Done” switch of theFIG. 21 screen, the system is ready to fill the syringe. It will benoted that during all of the set-up steps included on the screens ofFIGS. 18-21, the operator has the option of reverting to a prior screenby pushing the “Back” switch area on the screen.

Upon completion of the set-up instructions, before the system proceedswith filling of the syringe, the operator must activate the “OK” switchof the screen of FIG. 22. Upon activation of the “OK” switch, the systemwill proceed through an automated filling and purging operation. As thesyringe piston is withdrawn to the rear of the syringe, drawing contrastmaterial into the syringe, the screen of FIG. 23 will be displayed.Then, as the piston reverses direction and begins moving forward, airwill be purged out of the upper port of the syringe, during which timethe screen of FIG. 24 will be displayed. The syringe pistonautomatically stops before the lower valve within the patient manifoldmoves. Following the syringe purge operation, the screen of FIG. 25 willbe displayed, providing instructions to the operator as to how toproceed with the purging of the line from the syringes lower port to thesystem's high pressure line. In order to purge the line, the operatormust press and hold the “Purge” switch of the FIG. 25 screen andvisually observe the purging process as air and bubbles are pushed outof the line between the syringe and the patient manifold, and from thefront/nose of the patient manifold and out into the high pressure line.When this procedure has been completed, the operator releases the“Purge” switch and activates the “Done” switch of the FIG. 25 screen.When the operator is engaging the “Purge” switch, the screen of FIG. 26will be displayed. When the operator releases contact with the “Purge”switch, the screen of FIG. 25 will reappear. After the “Done” switch ofFIG. 25 has been activated, the display screen of FIG. 27 will bedisplayed.

The FIG. 27 process steps relate to the final saline flush procedure.When the operator engages the “Flush” switch of the FIG. 27 screen, thesystem will flush the line from the saline bag to the stopcock, assuringthat no air bubbles are present in the line. As long as the operatorcontinues to engage the “Flush” switch of the FIG. 27 screen, the screenof FIG. 28 will be displayed. Upon completion of the final saline flushprocedure, the operator will release the “Flush” switch and engage the“Done” switch of the screen of FIG. 27, which will cause the displayscreen of FIG. 29 to be displayed. The FIG. 29 screen is the finalstart-up screen. Following completion of the instructions of the FIG. 29screen, the operator activates the “Done” switch of the display,completing the start-up procedure, and the system is now ready forconnection to a catheter.

Upon successful completion of the start-up procedure described above,the system displays the MAIN screen, generally indicated in FIG. 30. TheMAIN display screen of the control panel of a preferred configurationthereof is divided into sections as illustrated in FIG. 30. It will beappreciated that all of the formatting for the display screen isprovided by and under control of the PC microprocessor 410. Referring toFIG. 30, there are four “function keys” vertically aligned along theright side of the screen and designated as “Inject” (500); “Saline”(501); “Aspirate” (502); and “Purge” (503). The icons for these fourfunction soft keys are aligned with appropriate switch pads of the touchscreen 432 so that an operator can press selected ones of the functionkeys and bring up the status window for the chosen function. The Statuswindow is indicated at 505, and an Indicator window is located at 506.The Status window is used to display system messages and to providefeedback to the user on the state of system operations. The Statusindicator window 506 displays key system sensors when they are active.

Three “Injection Type” or “Select Injection” keys indicated as LCA (leftcoronary artery) 508; RCA (right coronary artery) 509; and LV/Ao (leftventricle/aorta) 510 are positioned above the function keys and provideoperator input as to the type of injection procedure that will beperformed. The injection type can be changed by simply pressing one ofthese three type buttons. When a new type is selected, the defaultparameter values for the selected type are calculated and displayed inthe parameter keys. In the preferred embodiment (as hereinafterdescribed in more detail) the injection parameters are calculated basedon actual values such as weight of the patient to be treated. A verbalindication of the selected injection key is indicated at the very top ofthe display screen. In the sample screen indicated in FIG. 30, the LCAkey has been selected and its associated indication “LEFT CORONARY” isdisplayed at the top of the screen.

The following parameters can be changed by pressing the icon of thedesired parameter while the Injection Status window is open, or duringthe set-up procedure: Flow Rate; Injection Volume; Injection Pressure;and “Rise Time”. The injection parameter/limit keys are located alongthe top of the display screen.

A “Flow Rate” window 512 displays the greatest flow rate obtainable ifthe hand remote controller is completely depressed. The units for flowrate are ml/sec. An “Injection Volume” panel 513 displays the totalvolume limit that can be injected during a single injection. The unitsfor this parameter are ml. An “Injection Pressure” window 512 displaysthe maximum pressure within the syringe allowed during an injection. Ifthis pressure is reached, a warning light will come on and the injectionflow rate will be limited to the indicated pressure. The units forpressure are psi. A “Rise Time” window 515 displays the maximum risetime allowed during an injection. The units for rise time are seconds.

The system has the unique ability to either automatically or manuallyrefill the syringe, as described in U.S. Pat. No. 5,800,397, entitledAngiographic Injector System with Automatic High/Low PressureSwitching”, which is hereby incorporated by reference. The “Refill” keyis located in the lowermost portion of the display screen comprises the“Options” portion of the display screen. The Refill key, generallyindicated at 517 can be reset at any time during a case or procedure bysimply pressing the desired icon.

A second Option key generally indicated as the “Rate Type” key islocated at 518 which permits selection of the injection procedure aseither a “Fixed” rate or a “Variable” rate which can be controlled inreal time by the remote hand controller 14′.

The processor provides real-time information to the user on theinstantaneous conditions existing during an injection procedure. Theseconditions are displayed in the Status window 505 as indicated on thesample screen of FIG. 31. The display panel also displays the results ofthe last injection in a “Last Injection” window 520. The last injectionresults include the “total volume” and the “maximum flow rate” of thelast injection performed. The display panel also indicates thecumulative total of contrast material that has been injected in apatient for the current case, indicated in the “Contrast Total” displaywindow 522. The Last Injection and Contrast Total display windows arelocated near the lower left portion of the display screen. The ContrastTotal display provides important information to have instantaneouslyavailable during the injection procedure, since a case procedure mayinvolve numerous filling procedures of the syringe. Further, suchfilling procedures may represent either total or only partial filling ofthe syringe. Prior techniques depended upon the operator/user formaintaining a log of the total amount of contrast material that had beenadministered to a patient over the course of successive injections.Failure to maintain an accurate cumulative total for the amount ofcontrast material injected can result in overdose of injected materialto the patient.

In the preferred embodiment, a display window/key indicated as a“Patient's Weight” is indicated at 524. In the preferred embodiment,this display window displays the weight of the current patient.Selection of this key will allow the user to enter a patient's weight inkilograms into the system. The patient weight is used to calculateinjection values and limits (hereinafter described in more detail).

The final key on the display panel is the “End Case” key 526 locatednear the lower right portion of the display panel. Activation of thiskey will prompt the user through the proper steps before shut-down ofthe system or before starting a new case.

The Emergency button or switch 434 (FIG. 11) is physically located onthe upper right hand portion of the control panel. This is the onlyfunctional switch (besides the Power Supply switches) which is notlocated on the display screen. The Emergency switch disables anyon-going function and displays a message in the status window that theemergency button is engaged. The emergency button or switch is analternate action type of switch. When engaged, the button is lit. Todisengage the switch the user must press the button again.

The injection limits can be changed by pressing the key (512-515) of thedesired parameter. If the injection (key 518) is sot to a “Fixed” mode,a keypad will be presented to the user in the status window. Thiscondition is illustrated in FIG. 32. A new value can now be entered.This new value will be checked by the processor to see if it within anacceptable range for the type of ejections elected. If the entered valueis out of the acceptable range, a message will be displayed indicatingthis fact to the user. If the “Cancel” key is pressed, the previouslyset value will remain set. If the injection option (key 518) is set tothe “variable” mode, a choice of six different values are displayed inthe status window for the user to select. A sample display windowcorresponding to this situation is illustrated in FIG. 33. If the“Cancel” key is pressed, the previously set value will remain set.

An Injection is initiated by pressing the “Inject” button or key 500. Ifthe LV/Ao (large injection button), is selected, the user will be askedto confirm this. The LV/Ao injection procedure represents the largestvolume use of contrast material; whereas the RCA injection procedureuses the least amount of contrast material. The user is then asked byprompt on the display if it is okay to “Arm” the injection. The usermust press the “OK” key in the status window. At this point, if there isnot enough contrast in the syringe to perform the requested injection,the system will prompt for a refill. The refill will bc automatic ormanual, depending on the status of the “Refill” option key 517. When thevolume level is correct, the user will be prompted to activate the handcontroller 14′ for initiating the injection procedure.

If the volume injected is less than 10% of the volume limit, the numberof injections will not increase and the hand controller will remainarmed. A “large” injection requires the user to press “Large OK” againbefore another injection is permitted. The user exit the inject functionby pressing any key on the screen.

The Saline Flush function, initiated by activation of the “Saline” key501, pulls saline from the saline bag and flushes the disposable andline connections. When this function is initiated, the “Saline Flush”status window will be displayed with a “Flush” key and a “Done” key.Pressing the “Flush” key will flush the disposable with saline for up to10 seconds or until the user stops pressing the key. Pressing the “Done”button in the window will end the flush process and return the user tothe “MAIN” screen.

The Aspirate function draws line fluid back into the waste bag from thecatheter through the disposable. It may be used to remove bubbles ifthey are detected in the line. The aspirate function is initiated byselecting the “Aspirate” button or key 502 on the display panel. The“Aspirate” status window will be displayed on the screen. Pressing the“Aspirate” key will pull line fluid back through the disposable into thewaste bag as long as the “Aspirate” key is depressed, for up to 10seconds. Pressing the “Done” button will return the user to the “MAIN”screen.

The manual purge function is used to flush air from the disposable.There are two choices when purging, comprising the Syringe Purge and theLine Purge. Syringe Purge involves purging air out-of the syringe andwill be stopped when air has been purged from the syringe and the fluidpushes the syringe check valve closed. Line Purge purges air from thesyringe to the stopcock through the patient manifold. This method willsend contrast material through the disposable and will disengage thebubble detection device. This purge is done at system start-up in orderto clear air out of the interconnect of the syringe to the patientmanifold and the front on the patient manifold valve. During aprocedure, Line Purge may also be used when an air bubble remains withinthe disposal after the aspirator flush procedures have been tried. Toaccess the “Purge” function, the “Purge” key 503 is selected from the“MAIN” screen. The “Purge” status window will be displayed. Threeoptions are presented on the screen: “Syringe”, “Cancel”, and “Line”.Selecting “Cancel” will return to the “MAIN” screen. If “Line” isselected, the user is warned to disconnect the patient. The user mustacknowledge this by pressing the “okay” key. At this point, or if“Syringe” has been selected, a “Purge” key and “Done” key are displayedin the window. The “Purge” key is a press and hold key which willinitiate and continue the purging through the line or syringe until theuser releases the key, for up to 10 seconds. The purge will stopautomatically if the air is completely purged out and the contrast valveis successfully closed. If the user stops the purge before the valvecloses, a message will indicate that the purge is not complete. Pressingthe “Done” key or any other key on the screen will exit the purgefunction. A sample screen for a manual purge function is illustrated inFIG. 34.

If the automatic refill option is chosen by means of the key 517, thesyringe will automatically refill to 110 ml. if there is not enoughcontrast media within the syringe for the desired injection volumelimits. This will occur automatically at the time of injection. Ifmanual refill is chosen, the “Refill” status window will be displayed. A“Purge” key, a “Done” key, and a “Refill” key are active in this window.Pressing and holding down the “Refill” key will draw the plunger back,filling the syringe. The current amount of contrast media in the syringeis displayed as it fills. When the “Refill” button is released, therefilling operation discontinues. Pressing the “Purge” key will purgeair and fluid out of the syringe as long as the “Purge” key isdepressed. Pressing the “Done” button will send the user back to the“MAIN” screen. If there is still not enough contrast in the syringe tosatisfy the injection value of limits, the “Refill” status window willre-open at the time of injection. A sample screen for the manual refilloperation is illustrated in FIG. 35.

To end a case, the “End Case” button 526 is activated. A “Cancel” keyand an “End” key are displayed in the status box. If the “Cancel” key isselected, the user is returned to the “MAIN” screen. If the “End” key isselected, the end case sequence begins. When the high pressure line isdisconnected and the contrast container is removed from the receptacle,the “No Contrast” indicator will appear. If the “Done” button is thendepressed or selected, the plunger is automatically withdrawn from thesyringe body and the syringe can be removed from the system by unlockingand opening the chamber.

Prior systems have not provided automated determination of defaultinjection parameters that are directly related to values orcharacteristics of the patient to be treated. Such characteristics mightinclude such things as weight, age, wellness of the person, vascularrobustness, catheter size and the like. For example, prior systems haveincluded memory recall features for stored injection parameter valuesthat may have been stored by a physician for a particular patient or fora particular procedure wherein the stored parameters represent thetypical injection parameter choices of that physician. Variousembodiments of the present invention provides an automated method fordetermining suggested default injection parameter values just prior toan injection procedure, which injection parameter values are directlyrelated to values or conditions of the patient to be treated. In apreferred embodiment implementation of this method, the injectionparameter default values are calculated using the “weight” of thepatient. As stated above, however, other unique patient factors could beused in creating the default value calculations. For a preferredembodiment determination of the default injection parameters based onthe patient's weight, three different sets of formulas or algorithmshave been used, corresponding to the three different types of injectionsthat can be performed by the system (i.e., LCA, RCA or LV/Ao). For theLCA (Left Coronary procedure), the equations used for determining thefour injection parameter default values are:LCA Flow Rate Limit=3.5 Ln (weight)−7.6  Equation 1LCA Volume Limit=5.17 Ln (weight)−11  Equation 2LCA Rise Time=(flow rate+10)/100  Equation 3LCA Pressure Limit=(flow rate+20)25  Equation 4Table 1 provides a listing of calculated default injection parametervalues determined by Equations 1-4 for selected patient weights.

TABLE 1 LEFT CORONARY DEFAULT PARAMETERS FLOW RATE VOLUME RISE TIMEPRESSURE WEIGHT (MAX) (MAX) (MAX) LIMIT (KG) (ML/SEC) (ML) (SEC) (PSI)10 0 1 0.1 511 20 3 4 0.1 572 30 4 7 0.1 608 40 5 8 0.2 633 50 6 9 0.2652 60 7 10 0.2 668 70 7 11 0.2 682 80 8 12 0.2 693 90 8 12 0.2 704 1009 13 0.2 713 110 9 13 0.2 721 120 9 14 0.2 729 130 9 14 0.2 736The default injection parameters for a RCA (Right Coronary procedure)preferred embodiment, determined by Equations 5-8:RCA Flow Rate Limit=2.1 Ln (weight)−4.8  Equation 5RCA Volume Limit=2.7 Ln (weight)−  Equation 6RCA Rise Time=(flow rate+10)/100  Equation 7RCA Pressure Limit=(flow rate+15)25  Equation 8Table 2 provides a listing of values of the four injection parametervalues determined by Equations 5-8 for selected patient weights.

TABLE 2 RIGHT CORONARY DEFAULT PARAMETERS FLOW RATE VOLUME RISE TIMEPRESSURE WEIGHT (MAX) (MAX) (MAX) LIMIT (KG) (ML/SEC) (ML) (SEC) (PSI)10 0 0 0.1 376 20 1 2 0.1 412 30 2 3 0.1 434 40 3 4 0.1 449 50 3 5 0.1460 60 4 5 0.1 470 70 4 5 0.1 478 80 4 6 0.1 485 90 5 6 0.1 491 100 5 60.1 497 110 5 7 0.2 502 120 5 7 0.2 506 130 5 7 0.2 511Default injection parameter values for the LV/Ao injection selection(Left Ventricle/Aorta procedure), for the preferred embodiment, arecalculated according to Equations 9-12.LV/Ao Flow Rate Limit=7 Ln (weight)−16  Equation 9LV/Ao Volume Limit=22 Ln (weight)−46  Equation 10LV/Ao Rise Time=(flow rate+10)/100  Equation 11LV/Ao Pressure Limit=60 (flow rate)+200  Equation 12Table 3 illustrates default injection parameter values determined by9-12 for selected patient weights.

TABLE 3 LEFT VENTRICLE/AORTA DEFAULT PARAMETERS FLOW RATE VOLUME RISETIME PRESSURE WEIGHT (MAX) (MAX) (MAX) LIMIT (KG) (ML/SEC) (ML) (SEC)(PSI) 10 0 5 0.1 207 20 5 20 0.1 498 30 8 29 0.2 669 40 10 35 0.2 789 5011 40 0.2 883 60 13 44 0.2 960 70 14 47 0.2 1024 80 15 50 0.2 1080 90 1553 0.3 1130 100 16 55 0.3 1174 110 17 57 0.3 1214 120 18 59 0.3 1251 13018 61 0.3 1284

FIG. 36 illustrates comparative graphs for the default injectionparameter values for Flow Rate Limits determined according to Equations1, 5 and 9 respectively for the Left Coronary, the Right Coronary andthe Left Ventricle/Aorta functions for patient weights from 10-130 kg.

FIG. 37 illustrates comparative graphs of the Volume Limit defaultinjection parameter calculated according to Equations 2, 6 and 10 forthe Left Coronary, the Right Coronary and the Left Ventricle/Aortaselections respectively for patient weights ranging from 10-130 kg.

It will be appreciated that the automated determination of defaultinjection parameter values based on the patient's unique characteristics(such as weight), minimizes guess factors associated with selection ofproper default parameters for a particular patient, provides a method ofdetermining the default parameters which accommodates changes in thepatient's condition between injection procedures and eliminates therequirement for supplemental charts and graphs upon which the physicianor operator administering the injection procedure might have tootherwise rely in order to select or determine proper injectionparameter default values.

Accordingly, in order to determine a set of default injection parametervalues for a particular injection procedure, the user need simply selectone of the three injection selectors provided by selection buttons508-510 and to enter the patient's weight in kilograms in the patientweight window 524. A flow chart of this process is illustrated in FIG.38. Referring thereto, after the initial set-up process which includesan initial selection of the type of injection to be performed (block530) the operator enters the patient's weight (block 531). Themicroprocessor automatically determines the default injection parametersby using the appropriate algorithms therefor (block 532) according tothe selected injection procedure (i.e., LCA, RCA or LV/Ao) and accordingto the patient weight entered into the system through the display panel.The calculated default injection parameter values are then displayed onthe MAIN screen (block 533) to complete the process. The operator hasthe option of changing the determined values, but for most applicationsno changes to the default values will be required.

FIGS. 39A-C are views of a dual-syringe contrast injection system,according to one embodiment. FIG. 39A is a perspective view of thesystem 600. FIG. 39B is a view of the system 600 that shows variousinternal components. FIG. 39C is a top-view of a portion of the system600. The system 600 shown in these figures is a dual-syringe system thatincludes a control panel 602, and injection head 604, and a power supply(not shown). A first reservoir of medical fluid 610 is attached to theinjection head 604, and a second reservoir of medical fluid 606 is alsoattached to the injection head 604. In one embodiment, the reservoir 610comprises a bottle of sterile contrast media, and the reservoir 606comprises a bag of sterile diluent, such as saline.

The injection head 604 comprises various sub-components. For example,the injection head 604 includes a small display 608, first and secondsyringe/plunger assemblies 614 a and 614 b, first and second valve/airdetect assemblies 612 a and 612 b, and assembly 620. The assembly 620includes third and fourth valve/air detect assemblies. In oneembodiment, the valves used in these assemblies comprise pinch valves.These pinch valves may be actuated by a solenoid, pneumatic, or otherform of drive mechanism. The injection system 600 is capable of drawingfluid from the reservoir 610 into the first syringe/plunger assembly 614a via tubing 616 a, and is further capable of drawing fluid from thereservoir 606 into the second syringe/plunger assembly 614 b via tubing616 b. The tubing 616 a runs through the first valve/air detect assembly612 a, and the tubing 616 b runs through the second valve/air detectassembly 612 b. A door 613 a is used to cover the portion of the tubing616 a that runs through the assembly 612 a, and a door 613 b is used tocover the portion of the tubing 616 b that runs through the assembly 612b. In one embodiment, the doors 613 a and 613 b are transparent ortranslucent, and are each hinged to an outer edge of their respectivepinch valve/air detect assemblies (for opening an closing). In oneembodiment, the doors 613 a and 613 b are each hinged to an inner edgeof their respective valve/air detect assemblies.

The assembly 614 a is capable of expelling medical fluid into outputtubing 618 a, and the assembly 614 b is capable of expelling medicalfluid into output tubing 618 b. The output tubing 618 a runs through athird valve/air detect assembly, and the output tubing 618 b runsthrough a fourth valve/air detect assembly. A door 622 a is used tocover the portion of the output tubing 618 a that runs through the thirdassembly, and the door 622 b is used to cover the portion of the outputtubing 618 b that runs through the fourth assembly. In one embodiment,the doors 622 a and 622 b are transparent or translucent, and are eachhinged to an outer edge of the assembly 620 for opening and closing. Inone embodiment, the doors 622 a and 622 b are each coupled to a commonhinge assembly on the top portion of the assembly 620 for opening andclosing.

In one embodiment, the air detectors comprise air-column detectors. Theair detectors are also capable of detecting air bubbles, according toone embodiment.

The system 600 further includes both a main control panel 602 and also asmall control panel 608. An operator of the system 600 may use the maincontrol panel 602 to set up one or more parameters of an injectionprocedure prior to initiation of the procedure. The operator may alsouse the main control panel 602 to modify one or more aspects,parameters, etc. of an injection procedure during the procedure, or mayalso use the panel 602 to pause, resume, or end an injection procedureand begin a new procedure. The control panel 602 also displays variousinjection-related information to the operator, such as flow rate,volume, pressure, rise time, procedure type, fluid information, andpatient information. In one embodiment, the main control panel 602 maybe connected to a patient table, while being electrically coupled to theinjector head 604. In this embodiment, the operator may manually movethe main panel 602 to a desirable location, while still having access toall functionality provided by the panel 602.

In one embodiment, the small panel 608 provides a subset of functionsprovided by the main panel 602. For example, the operator may use thesmall panel 608 to manage injector setup. The operator may interact withthe small panel 608 to manage the setup of the injector. The small panel608 may display guided setup instructions that aid in this process. Thesmall panel 608 may also display certain error and troubleshootinginformation to assist the operator. For example, the small panel maywarn the operator of low contrast or saline fluid levels in the liquidreservoirs and/or syringes In one embodiment, the small panel 608provides unique display functionality and/or additional functions withregards to the main panel 602, as will be described in more detailbelow.

In one embodiment, there is further provided an additional remotedisplay (not shown) that may be the size of a personal digital assistant(PDA). This additional remote display may be in communication with themain control panel 602 via a wireless connection, according to oneembodiment. A physician may utilize this additional remote display withflexibility, because the display is mobile. Due to its size, theadditional display is also very portable and convenient to use. Theremote display is capable of receiving user input and providing displayinformation as output, and may provide a subset of functionality that isprovided by the main panel 602, according to one embodiment. In oneembodiment, the additional remote display provides unique displayfunctionality and/or additional functions with regards to the main panel602.

In one embodiment, the output tubing 618 a and 618 b includes a reusableportion and a single-use portion. In this embodiment, the single-useportions of the output tubing 618 a and 618 b are coupled to the patientcatheter and are discarded after a patient procedure. The reusableportions are those portions of the tubing that are directly coupled tothe outputs of the syringe assemblies 614 a and 614 b. The reusableportions and single-use portions may be coupled by fluid connectors,according to one embodiment. The valves in the assembly 620 (such aspinch valves) help prevent cross-contamination.

In one embodiment, the tubing 616 a is coupled to a fluid input port ofthe syringe assembly 614 a, and the tubing 616 b is coupled to a fluidinput port of the syringe assembly 614 b. The output tubing 618 a (or atleast its reusable portion, in one embodiment) is coupled to a fluidoutput port of the syringe assembly 614 a, and the output tubing 618 b(or at least its reusable portion, in one embodiment) is coupled to afluid output port of the syringe assembly 614 b.

In one embodiment, the reservoir 606, the reservoir 610, the tubing 616a and 616 b, the syringe assemblies 614 a and 614 b, along with thereusable portions of the tubing 618 a and 618 b are disposablecomponents that may be reused across multiple patient procedures. Thesingle-use portion of the tubing 618 and 618 b are disposable componentsthat are to be used for a single patient procedure only and discardedafter such use.

FIG. 39B shows an internal view of certain components of system 600.FIG. 39B shows two motor/actuator assemblies 630 a and 630 b. Each motorin an assembly drives one of the linear actuators. Each linear actuatordrives a plunger of one syringe. For example, the linear actuator in themotor/actuator assembly 630 a can drive a plunger in the syringeassembly 614 a, and the linear actuator in the motor/actuator assembly630 b can drive a plunger in the syringe assembly 614 b. An individualplunger is capable of moving within the syringe barrel in either aforward or rearward direction. When moving in a forward direction, theplunger injects liquid into the patient line. For example, when aplunger within the syringe assembly 614 a moves in a forward direction(to the left in FIG. 39B), the plunger is capable of injects liquid intothe output tubing 618 a. When moving in a rearward direction (to theright in FIG. 39B, the plunger is capable of filling liquid into thesyringe assembly 614 a from the reservoir 610.

As shown in FIG. 39B, the assembly 612 a comprises a valve 632 a and anair detector 634 a. Likewise, the assembly 612 b comprises a valve 632 band an air detector 634 b. In one embodiment, the valves 632 a and 632 bcomprise pinch valves. Each valve 632 a and 632 b may bc opened orclosed by the system 600 to control the fluid connections leading tosyringe assemblies 614 a and 614 b, respectively. For example, thesystem 600 may open the valve 632 a to fill fluid from the reservoir 610into the syringe assembly 614 a. The system 600 may also open the valve632 b to fill fluid from the reservoir 606 into the syringe assembly 614b. The system 600, in one embodiment, is capable of filling syringeassemblies 614 a and 614 b at the same, or substantially the same, time.The system 600 may close the valves 632 a and/or 632 b during injectionof fluid. For example, the system 600 may close the valve 632 a when thesyringe assembly 614 a is being used to inject fluid from the assembly614 a into the output tubing 618 a.

The air detectors 634 a and 634 b detect the presence of air columns orair bubbles in the associated tubing 616 a and 616 b. These detectorsmay include optical, acoustic, or other form of sensors. When one ormore of these sensors generates a signal indicating that air may bepresent in a fluid line leading to the syringe 614 a and/or 614 b, thesystem 600 may warn the user or terminate an injection procedure,according to one embodiment.

In the embodiment of FIG. 39B, the assembly 620 includes output valves636 a and 636 b, as well as output air detectors 638 a and 638 b. In oneembodiment, the valves 636 a and 636 b comprise pinch valves. The system600 controls the output valves 636 a and 636 b to control when fluid maybe injected into a patient via the output tubing 618 a and/or 618 b. Forexample, the system 600 may open the valve 636 a to allow the assembly614 a to inject fluid into the output tubing 618 a. The system may alsoopen the valve 636 b to allow the assembly 614 b to inject fluid intothe output tubing 618 b. In one embodiment, the system 600 can injectfluid from syringe assemblies 614 a and 614 b into output tubing 618 aand 618 b at the same, or substantially the same, time. In thisembodiment, both of the valves 636 a and 636 b would be open. The system600 may close the valves 636 a and 636 b when the system 600 is fillingfluid from the reservoirs 610 and/or 606 into the corresponding syringeassembly. For example, the system 600 may close the valve 636 a when itfills fluid from the reservoir 610 into the syringe assembly 614 a. Inthis case, the valve 632 a would be open.

The air detectors 638 a and 638 b function similarly to the detectors634 a and 634 b, though they are located further downstream in theassociated output tubing 618 a and 618 b, respectively. These detectors638 a and 638 b provide signals to the system 600 when they detect airbubbles or air columns in the associated tubing. When the system 600receives and processes any such signals from the detectors 638 a or 638b, the system 600 can alert the user, or may also automatically abort,or stop, an injection procedure to prevent the injection of air into apatient.

In one embodiment, the system 600 opens one or more of the valves 632 a,632 b, 636 a, or 636 b when a user manually loads certain componentsinto the system 600. For example, the system 600 may open an inputvalve, such as the valve 632 a, when the user manually loads a syringeassembly and tubing, such as the assembly 614 a and the tubing 616 a. Inanother example, the system 600 may open an output valve, such as thevalve 636 b, when the user manually loads output tubing, such as thetubing 618 b.

FIG. 39C shows a top view of a portion of the system 600. FIG. 39C showsan example of contextual lighting that may be used, according to oneembodiment. In this embodiment, contextual lighting is associated witheach valve and air detector. Lighted displays 650 a and 650 b areassociated with the valves 632 a and 632 b, respectively, and arelocated in proximity to these components. In one embodiment, the lighteddisplays are adjacent to the associated components. Lighted displays 652a and 652 b are associated with the air detectors 634 a and 634 b, andare located in proximity to these components. Lighted displays 654 a and654 b are associated with the valves 636 a and 636 b, and are located inproximity to these components. Lighted displays 656 a and 656 b areassociated with the air detectors 638 a and 638 b, and are located inproximity to these components. The individual lighted displays helpindicate to an operator where specific components (such as the valvesand air detectors) are located in the system 600. In one embodiment, thelighted displays 650 a, 650 b, 652 a, 652 b, 654 a, 654 b, 656 a, and656 b comprise lighting patterns, such as lighted graphics.

In one embodiment, the system 600 provides a guided setup mode to a userwho may be less familiar, or experienced, with the system 600. In thisembodiment, the contextual lighting helps guide a user as to how tosetup the system 600 for use. For example, the system 600 may cause oneor more of the lighted displays to blink, change color, or provideanother visual indication that setup is to proceed in a certain fashion,or that certain conditions exist. In one scenario, the system 600 maycause the display 650 a to blink, indicating that the user is to loadthe tubing 616 a through the valve 632 a. Once the user has successfullyloaded the tubing or otherwise properly performed a setup function, thesystem 600 may then causes the lighted display 650 to display a solid(non-blinking) light to indicate that loaded is complete, or successful.Similarly, a change in color of a display (e.g. red to green) mayindicate that a step has been completed successfully. The remainingdisplays 650 b, 652 a, 652 b, 654 a, 654 b, 656 a, and 656 b may becontrolled in a similar fashion during a guided setup. In oneembodiment, the system 600 will not solidly light the lighted display(indicating successful loading) until the user has closed theappropriate loading door 613 a, 613 b, 622 a, and/or 622 b or until theuser has otherwise properly performed setup.

In one embodiment, the system 600 further provides an express setup modefor a user who is quite experienced in using the system 600. In thisembodiment, the user may load the system components at the user'sdiscretion, and the system 600 will light the displays after the userhas successfully completed loading individual components or otherwiseproperly performed one or more setup functions. For example, after theuser has loaded the output tubing 618 b through both the valve 636 b andthe air detector 638 b, the system 600 can cause the lighted displays654 b and 656 b to visual display solid lights, indicating that the userhas successfully completed loaded the output tubing 618 through thesecomponents. The system 600 may also cause one or more lighting patternsto display light of a specified color, such as green, to indicatesuccessful loading.

In one embodiment, the system 600 may also cause the lighted displays todisplay identified colors to indicate potential or actual errorconditions, or to indicate that the user has improperly performed asetup function. For example, the system 600 may cause the display 650 bto show a solid, red color to indicate to the user that the valve 632 bhas malfunctioned. Or, the system 600 may cause the display 656 a toshow a solid, red color to indicate to the user that the air detector638 a has detected a presence of air. Various other visual or graphicalpatterns, displays, and the like may be provided for the lighteddisplays 650 a, 650 b, 652 a, 652 b, 654 a, 654 b, 656 a, and 656 b inthe system 600.

FIGS. 40A-B and 41A-B are perspective views of certain embodiments ofdisposable fluid connections that may be used in a powered injectionsystem, such as the system 600. Although the examples shown in thesefigures highlight disposable connections that may be used in adual-syringe injection system, other embodiments provide use of theseconnections in injection systems having other configurations, forexample as a syringe and a peristaltic pump, such as the system shown inFIG. 42. In various embodiments, the disposable fluid connections may becoupled to one or more pressurizing units, such as a syringe, aperistaltic pump, or other form of pump. Various embodiments of adisposable fluid connector help minimize the number of connections thatare required to a powered injection system and/or to a patient line.

FIG. 40A shows one embodiment in which a disposable fluid connector 682may be used with the injection system 600. In this embodiment, thedisposable fluid connector 682 may be loaded into an assembly portion680 of the injection head 604. As such, the connector 682 is coupled asone single assembly to the injector. FIG. 40B shows an example of theconnector 682 after it has been loaded into the portion 680. Theconnector 682 is used only for a single patient procedure (single use),according to one embodiment. In this embodiment, the connector 682 isdiscarded after is has been used for an injection procedure on aparticular patient. In one embodiment, the connector 682 is referred toas a “disposable cassette” that may be loaded and unloaded as oneassembly into the portion 680 of the injector head 604. The portion, ormember, of the connector 682 that scats onto a top portion of theportion 680 is made of a resilient material, such as plastic, accordingto one embodiment. This member is non-removably attached to both thetubing 686 a and 686 b, according to one embodiment. When manipulatingthe connector 682, or loading/unloading the connector 682 into theportion 680, a user may grasp and/or manipulate the member that isnon-removably attached to both the tubing 686 a and 686 b. This allowsthe user to more easily and conveniently handle the connector 682,according to one embodiment. In one embodiment, the member may beremovably connected to both the tubing 686 a and 686 b.

The connector 682 shown in FIG. 40A-B includes output tubing 686 a and686 b. The connector 682 further includes a connection 684. Theconnection 684 may be used to connect the connector 682 to an externalmedical device or to an external signal. The connection 684 is coupledto the injection head 604. For example, in one embodiment, theconnection 684 may be connected to a pressure transducer, such that thesystem 600 may monitor hemodynamic signals. In this embodiment, a cableis used to connect the pressure transducer to the connection 684. Theconnection 684 includes an RJ-11 connector, and signals from thepressure transducer can then be routed to the system 600 via connection684 for processing. In one embodiment, a cable may be used to directlyconnect an external medical device, such as a hemodynamic monitoringdevice or a balloon inflation device, to the system 600 via theconnector 684. In one embodiment, the system 600 is capable of detectingthe presence of the connector 682 to the head 604 by means of theconnection 684. In this embodiment, the system 600 detects the presenceof the connection 684 by way of an electrical connection to the portion680 of the head 604.

As shown in FIG. 40A-B, the output tubing 686 a and 686 b rest inseparate grooves, or channels, of the portion 680 when the connector 682is loaded. The output tubing 686 a and 686 b comprise the single-useportions of the output tubing 618 a and 618 b, respectively. The tubing686 a and 686 b are used only for a single use (patient), and arediscarded after an individual patient procedure, according to oneembodiment. The tubing 686 a and 686 b have proximal ends that arecoupled to the respective portions of output tubing 618 a and 618 b thatare reusable across multiple patient procedures and that are directlycoupled to the output ports of the syringe assemblies 614 a and 614 b,respectively. The tubing 686 a and 686 b have distal ends that can eachbe coupled to a patient line connected to the patient. The use of thevalves 636 a and 636 b (such as pinch valves) aid in the prevention ofcross-contamination of the reusable portions of the output tubing 618 aand 618 b. In one embodiment, the tubing 686 a and 686 b are coupled toa fluid valve, such as the elastomeric valve shown and described inreference to FIGS. 55A and 55B (below). In this embodiment, the tubing686 a is coupled to a first input port of the valve, and the tubing 686b is coupled to a second input port of the valve. The output port of thevalve is then coupled to the patient line. The valve controls the flowof fluid through the tubing 686 a or 686 b to the patient line.

FIGS. 41A-B are perspective views of disposable fluid connections thatmay be used in a powered injection system, such as the system 600,according to another embodiment. FIG. 41A shows an example of adisposable connector 690 that may be used in the system 600, and FIG.41B shows an example of the connector 690 after it has been loaded intoan assembly portion 696 of the injector head 604. The connector 690includes a connection 692 that is similar to the connection 684 shownand described previously. The connector 690 comprises a component forloading into the portion 696 having a larger size than the connector 682shown in the previous figures. In one embodiment, this larger-sizecomponent slides into and over a receptacle area of the portion 696, andthe output tubing 686 a and 686 b are located in close proximity as theypass through a narrow groove, or channel, of the portion 696.

FIG. 42 is a perspective view of a powered injection system 700 thatincludes a syringe 714 and a pump, such as a peristaltic pump 724,according to one embodiment. In this embodiment, the syringe 714 is usedto deliver a first medical fluid, such as contrast media, to a patient,and the pump 724 is used to deliver a second fluid, such as a salinediluent, to the patient. The system 700 also includes a main controlpanel 702, a small control panel 708, a first fluid reservoir 710, asecond fluid reservoir 706, input tubing 716, output tubing 718 a and718 b, an assembly 720, and doors 722 a and 722 b.

In one embodiment, the control panel 702 is similar in shape andfunction to the panel 602 shown in FIG. 39A, and the small panel 708 issimilar in shape and function to the panel 608. The reservoir 710contains a first medical fluid, Such as contrast media, and thereservoir 706 contains a second fluid, such as saline. As is shown inthe example of FIG. 42, the reservoir 710 is a glass bottle and thereservoir 706 is a plastic bag. In other embodiments, other reservoirtypes may be used. The fluid within the reservoir 710 is filled into thesyringe 714 through tubing 716 upon retraction of a plunger within thesyringe 714. The system 700 is capable of controlling movement of theplunger. In one embodiment, the system 700 controls movement of theplunger upon receipt of user input, such as user input from ahand-control device or user input provided on the panel 702 and/or 708.The fluid within the reservoir 706 is moved through the tubing 718 b byoperation of the peristaltic pump 724. The pump 724 is also controlledby the system 700.

Medical fluid contained within the syringe 714 may be injected into thepatient via output tubing 718 a, and medical fluid from the reservoir706 may be injected into the patient via output tubing 718 b throughoperation of the pump 724. The output tubing 718 a and 718 b areoperatively connected to a patient catheter in one embodiment.

In one embodiment, the tubing 18 a comprises a single-use portion and amulti-use portion. The single-use portion is operatively coupled to thepatient line (catheter), and the multi-use portion is coupled to theoutput of the syringe 714. The single-use portion and the multi-useportion are coupled via a connector.

In one embodiment, the reservoir 706, the reservoir 710, the tubing 716,the syringe 714, and the reusable portion of tubing 718 a are disposablecomponents that may be re-used across multiple patient procedures,whereas the single-use portion of tubing 718 a and the tubing 718 b aredisposable components that are used only for a single patient procedure.The assembly 720 includes two valve and air-detector assemblies (oneeach associated with the syringe 714 and the pump 724). The doors 722 aand 722 b are hinged to the assembly 720 and function similarly to thedoors 622 a and 622 b. In one embodiment, the system 700 furtherincludes a valve and an air detector (not shown) between the reservoir710 and the syringe assembly 714, similar to valve 632 a and airdetector 634 a shown in FIG. 39B. The tubing 716 runs through this valveand through the air detector. In one embodiment, the valves comprisepinch valves.

In one embodiment, there is further provided an additional remotedisplay (not shown) that may be the size of a personal digital assistant(PDA). This additional remote display may be in communication with themain control panel 702 via a wireless connection, according to oneembodiment. A physician may utilize this additional remote display withflexibility, because the display is mobile. Due to its size, theadditional display is also very portable and convenient to use. Theremote display is capable of receiving user input and providing displayinformation as output, and may provide a subset of functionality that isprovided by the main panel 702, according to one embodiment. In oneembodiment, the additional remote display provides unique displayfunctionality and/or additional functions with regards to the main panel702.

FIG. 43-FIG. 54 illustrate various embodiments of screen displays thatmay be provided within a graphical user interface (GUI) in a poweredinjection system, such as, for example, the system 600 shown in FIG. 39Aor the system 700 shown in FIG. 42. These screen displays may beprovided on a control panel of the system, such as the control panels602, 608, 702, and/or 708 shown and described previously. In oneembodiment, these screen displays may also be provided on an additional,small, remote and portable display that is coupled to the main panel.Examples of such small, remote displays have been described previously.

In one embodiment, the screen display shown in FIG. 43 is provided on amain console, or control panel, of the system, such as the control panel602 or 702. As shown in FIG. 43, the user of the system can interactwith the screen display that is provided, since the control panelincludes a touch-screen interface. In one embodiment, the control panelalso includes hard buttons that may be depressed by the user to provideinput to the system. In other embodiments, other forms of userinterfaces (such as voice activated, hand controlled, foot controlled)may be used.

The user may select the type of procedure to be performed by selectingone of the displayed options. In FIG. 43, the displayed options are“LCA” (left coronary artery), “RCA” (right coronary artery), and “LV/Ao”(left ventricle/aorta). Each option is associated with a correspondinggraphical symbol, such as an icon. Each symbol is associated withinformation about a medical procedure that may be performed on apatient. In one embodiment, the symbols each represent an anatomicallocation of a patient (e.g., LCA, RCA, LV/Ao) that is associated withthe medical procedure to be performed, as shown in the example of FIG.43. In this example, the user has selected “LCA”. In one embodiment, thesymbols each represent a type of medical device or equipment that is tobe used in performing the medical procedure.

Once the user has made a selection, default injection parameters forthat selection, which are associated with the corresponding medicalprocedure, are retrieved and displayed to the user. In the example ofFIG. 43, default parameters for the selection “LCA” are displayed, whichare associated with an injection procedure into the left coronaryartery. These default parameters are stored within the system and areconfigured by the manufacturer, in one embodiment. In one embodiment,the user has the ability to customize the default parameters that arestored. These parameters apply to an individual patient injectionprocedure. After the parameters are displayed to a user, the user maythen modify one or more of the parameters using the GUI, according toone embodiment.

The use of the graphical symbols, or icons, helps provide the user withquick and recognizable graphics associated with the appropriateprocedure to be performed. This can help improve workflow and speed ofsetup, as well as possibly help prevent mistakes. In one embodiment, thegraphical icons can also be displayed in different colors to indicatethe status, or state, or the device. In one embodiment, different colorsmay be used for the following states: unselected, selected, armed(injector), and touched (by the user). For example, after a user hasselected one of the options, the system may prominently display theselected option within the GUI by changing the color of the selectedoption (and corresponding graphical symbol).

In FIG. 43, the user may modify the maximum injection volume, themaximum flow rate, the rise time, and maximum injection pressure. Thescreen display also includes bar indicators, along with associatednumeric values, to indicate the amount of contrast or saline remainingin the associated contrast reservoirs (such as reservoirs 706 or 710).The user may press the “inject” button to cause an injection of fluid tocommence, or may press the “refill” button to cause a refill operationto commence. The user may press “inject” for one fluid medium (such ascontrast) and press “refill” for the second fluid medium (such assaline) at the same, or substantially the same, time (according to oneembodiment). In one embodiment, the system has knowledge of reservoirsize/volume based upon previously entered input into the system.

FIG. 44 shows an example of active and inactive screen portions on thedisplay, according to one embodiment. In this embodiment, the screenwindow entitled “Adjust settings” is the active window, and all otherbackground menus or windows are inactive (grayed out). In this fashion,the user's focus may be directed solely to the active portion of thedisplay, while the rest of display is entirely disabled. In thisexample, the user's attention is directed solely to the adjustment ofsettings, based upon the user's prior selection for modification. Theactive window may bc used by the user to adjust maximum pressure, risetime, and KVO (keep vein open) flow (if the KVO feature is turned on).

FIG. 45 shows a screen display similar to the one shown in FIG. 43. Thedisplay of FIG. 45, however, includes a few additional features. Asshown, the screen display provides additional details, such as the flowrate of the prior injection, the injection volume of the priorinjection, and the total amount of fluid injected for the given case.The screen display also provides details about the current size of thecatheter being use, the calculated pressure of injection, the rise time,and the rate for KVO. In addition, the screen display provides controlsand settings at the bottom of the screen for controlling and managing anexternal medical device, such as a balloon inflation device(“indeflator”, for inflation/deflation). In one embodiment, the ballooninflation device may be an automated inflation device. Using the GUI onthe screen display, the user may arm/disarm the inflation device, selectthe type of balloon/stent/etc. that is to be used in the procedure, andadjust various inflation/deflation parameters, such as pressure and timeon inflation/deflation. The screen display shown in FIG. 45 provides theuser with a myriad of options for controlling multiple medical devicesfrom a single GUI displayed on a control panel.

FIGS. 46A and 46B show exemplary screen displays that may be provided toa user for customization of various injection settings, or parameters,for a particular individual, such as a physician. Because an individualinjection system may be used over time by multiple different physiciansor operators, it may often be useful for physicians to create a profile,or multiple profiles, for their own selected, or preferred, settings forgiven procedure types or scenarios. When an individual user wishes touse the system, that user may then recall his or her profile(s) ofpreferences as stored in the system quickly and conveniently.

As shown in FIG. 46A, a user has selected procedures for an exemplaryphysician. Various procedures are displayed, such as “pediatricperipheral”, “pediatric coronary”, and “pediatric carotids”. A defaultset of procedures may be loaded into the system by the manufacturer, butmay further be customized by the user. Within individual proceduretypes, the system may display additional categories of patients, such asages or age groups of patients.

In the example of FIG. 46B, the user has selected “Age 5-7” for thegeneral procedure type of “Pediatric Peripheral” for the indicatedphysician. For this physician, the indicated parameters would bc storedas default parameters for the specified procedure type and patientfalling within the designated age range. As is shown in FIG. 46B, thescreen displays parameters for specific procedures for the selectedtype. These exemplary procedures are “Left Coronary”, “Right Coronary”,and “Left Ventricle”. Associated graphical representations, or icons,are displayed next to the textual descriptions of the procedures. Alsoshown are the designated parameters for each procedure, such as maximuminjection volume and maximum flow rate. The user may select or changeany of the procedure parameters for use with the indicated physician,and these may then be saved into the system for later use.

FIG. 47 shows an exemplary screen display with an error indicator. Asshown, this particular error indicator graphically indicates to the userof a specific warning. In this scenario, the warning indicates that thecontrast bottle is empty. In this embodiment, the user must click on the“OK” button before returning to the screen that had previously beendisplayed. The warning window provides another example of a highlightedwindow of focus that is displayed to the user, while all other windowsand/or portions of the GUI are dimmed/grayed out and out of focus. Inone embodiment, the warning shown in FIG. 47 is displayed in aparticular color, such as yellow. In this embodiment, one color is usedfor certain types of warnings, and other colors are used for other typesof warnings, or errors. The use of colors assists the user in quicklyand accurately identifying and resolving issues that may occur, or haveoccurred, in the system.

FIG. 48 through FIG. 50 provide examples of screen displays that may beprovided by the system for setup of the injection system (such as thesystem 600 or 700). In one embodiment, the setup screens are capable ofbeing provided on both a main control panel (such as the panel 602) anda small panel on the injection head (such as the panel 608). In thisembodiment, the main control panel may be capable of providing certainsetup information (or setup screens), while the small control panel maybe capable of providing other setup information (or screens), based uponthe type or sequence of setup information. In one embodiment, the setupscreens are provided only on either the main control panel or the smallcontrol panel. In one embodiment, the setup screens may also be providedon a small, remote, portable panel (that may be the size of the PDA), aswell.

In one embodiment, the injection system provides both a guided setup andan express, or expert, setup mode. The guided setup mode may bc used bya user who is somewhat less familiar, or experienced, with the system,or who may want more specific instructions as to how to use the system.In the guided setup mode, contextual lighting on the injection head mayfurther help guide a user as to how to setup the system for use. Forexample, while proceeding through instructions on the GUI (graphicaluser interface on the console) for the guided setup mode, the system maycause one or more of the lighted displays, such as patterns, on theinjection head to blink, change color, or provide some other form ofvisual indication that setup is to proceed in a certain fashion, or thatcertain conditions (such as error conditions) exist. For example, in onescenario, the GUT may specify that the user is to load the contrastsyringe. On the injection head, the contextual lighted displayassociated with contrast syringe may blink in a particular color, suchas yellow, to instruct the user where to take action. The GUI may thenprovide graphical and textual instructions to the user regarding loadingof the contrast syringe. In this fashion, the user receives guided setupinstructions from the GUI and corresponding indicators (via contextuallighting) on the injector head to provide setup assistance. Additionalinstructions may be provided for other setup tasks, such as loadingreservoirs, loading tubing, loading cartridges, installing handcontroller to the system, and the like. Different colors and colorpatterns may also be used. For example, the system may provide yellowlights/lighting patterns to indicate that certain setup steps are to beperformed, white lights/patterns to indicate that certain setup stepshave been successfully performed, or red lights/patterns to indicatethat one or more errors have occurred. In addition, the system mayprovide blinking or solid light patterns for different statusconditions. For example, the system may provide blinking lights toindicate that certain setup steps are to be performed, or provide solidlights to indicate that certain setup steps have been completed.

In one embodiment, the system further provides an express, or expert,setup mode for a user who is more experienced in using the system, orwho may not wish to go through an interactive setup procedure. In thisembodiment, the user may load the system components at the user'sdiscretion, and the system will implement certain lighting patterns toindicate that the user has successfully completed certain setup phases.For example, after the user has loaded tubing through both a valve andan air detector, the system can cause the lighted displays on theinjection head to visual display solid lights, indicating that the userhas successfully completed loaded the tubing. The system may also causeone or more lighting patterns to display light of a specified color,such as green, to indicate successful loading. FIG. 49 shows an exampleof a GUI that may be used by the user to select either the guided orexpert setup mode. A graphical representation of the injector head,along with its coupling to the hand controller, is displayed. Differentlights and lighting patterns may be used once setup is initiated.

FIG. 48 shows one example of a GUI that may be provided on the consoleduring initial setup of the injector in the guided and/or express mode.A graphical representation of various components of the injection headis shown within the GUI, such as the fluid reservoirs, the syringes, andthe various different valve/air detector assemblies. The icon and lightcolor coding that is used with the graphical representation indicatesthat saline has been loaded from the saline reservoir into the syringe.Contextual lighting patterns on the injection head may also be used inconjunction with the instructions on the GUI during this initial setup.If the user has selected the guided setup mode, the system would displayon the GUI the next setup step, or instruction, after the saline hasbeen successfully loaded. By using various forms of visual indicatorswithin the GUI (such as, for example, graphical symbols or textualinstructions), the system is capable of indicating to a user whichspecific setup function, or functions, are to be performed oncorresponding components of the system. In one embodiment, graphicalsymbols such as arrows or even colored highlighting may be used withinthe GUI. The graphical symbols may be displayed in various differentcolors. In a guided setup mode, the GUI may provide a series of visualindicators or instructions to provide the user with detailed setupinstructions for the system.

FIG. 50 shows an example of a GUI that may be provided during a guidedsetup procedure, according to one embodiment. In this example, the GUIprovides instructions to the user for setting up the contrast syringe.The GUI provides a graphical representation of the contrast syringeloaded in the injector head, along with representation of input andoutput tubing. The input tubing, as shown, runs through a valve and anair detector. The textual instructions within the GUI indicate that theuser is to open the contrast syringe chamber, place the syringe withinthe chamber, and then close the chamber. The combination of graphicaland textual information within the GUI provides the user with multipleforms of useful information during the setup process.

FIG. 51 through FIG. 54 provide examples of graphical information thatmay be displayed within a small control panel, such as the panel 608 and708. FIG. 51 shows an example of a screen that may be provided within aGUI to display details and parameters for a left coronary injectionprocedure. The user may modify the maximum volume of medical fluid to bedelivered during the procedure, along with the maximum flow rate, usingthe “+” and “−” buttons. In one embodiment, these buttons arehard-buttons provided on the housing of the control panel. In oneembodiment, these buttons are provided within a touch-screen panel. FIG.51 also displays the rise time and calculated or measured fluidpressure, as well as bar indicators for the amount of fluid remaining inthe contrast and saline fluid reservoirs. When a user is not located inproximity to the main control panel, the user may find informationdisplayed on the small control panel (located on the injector head) tobe of particular use and convenience.

FIG. 52 provides another example of setup information that may beprovided within a GUI. As shown, this particular example providesinformation pertinent to a guided setup process. The textual informationinstructs a user to place tubing through a valve and to close the door.The graphical information shows a representation of the tubing placedthrough the valve, with an arrow pointing to the valve foridentification by the user.

FIG. 53 provides an example of a bottle selection screen. Throughinteraction with the GUI, the user may select the contrast bottlevolume, or size, that is to be used, according to one embodiment. Asshown FIG. 53, the user may select from the displayed options by atouching button 800, 802, 804, or 806. The volume, or size, of theprevious contrast reservoir that was used is also displayed in the GUI.In one embodiment, the buttons 800, 802, 804, and 806 are hard buttons.In one embodiment, the buttons 800, 802, 804, and 806 are buttons thatare selectable on a touch-screen.

FIG. 54 provides an example of a warning that may be displayed to theuser. For example, this warning may be provided on the screen displayshown in FIG. 51 on a small control panel. This particular warningindicates that a fluid reservoir is running low on fluid. An icon, orgraphical representation, is displayed next to the corresponding barindicator. In FIG. 54, the warning indicates that the contrast reservoiris low. When a user sees this warning, the user is aware the replacementmay bc imminently required. A separate warning or error indicator may bcdisplayed when the contrast reservoir is actually empty.

Various screens may be displayed on a remote, small display or controlpanel. This remote panel may communicate with the main panel using awireless connection, according to one embodiment. In one embodiment, theremote panel is portable and small, such as the size of a PDA (personaldigital assistant). The screen size of the remote panel may be smallerthan that of the main panel, according to one embodiment, but may stillbe capable of providing a large amount of display information to a user,including information in a plurality of different colors. The user mayalso be able to input information using the remote panel, according toone embodiment, that is then transmitted back to the main panel.

FIG. 55A is a perspective view of one embodiment of a valve that may beused with a powered injection system. For example, the valve may be usedwith the system 600 shown in FIG. 39A or in the system 700 shown in FIG.42, according to one embodiment. In one embodiment, the valve comprisesan elastomeric valve assembly that is part of a patient line, single-usekit. The valve as shown in FIG. 55A includes a first input port 900, asecond input port 904, a transducer connection 902, and an output port906. The transducer connection 902 may be coupled to a pressuretransducer for use in monitoring hemodynamics. The pressure transducermay then be coupled to a hemodynamic monitoring system. The input port900 may be connected to a first fluid output line, such as the outputtubing 618 b shown in FIG. 39A. In one embodiment, the input port 900 iscoupled to a low-pressure line. The input port 904 may be connected to asecond fluid output line, such as the output tubing 618 a. In oneembodiment, the input port 904 is coupled to a high-pressure line. Theoutput port 906 is coupled to a patient line that leads to a catheter.Fluid is expelled out of the port 906 and injected into a patient inthis embodiment. In one embodiment, the valve functions as a one-wayvalve that allows fluid to flow from either port 900 or 904 to port 906,but not in the opposite direction. In one embodiment, the valve may becapable of providing bi-directional fluid flow.

FIG. 55B is a perspective view of another embodiment of a valve that maybe used with a powered injection system, such as the system 600 orsystem 700. In this embodiment, the valve comprises a first input port910, a second input port 914, an output port 916, and a vent 912. Thevalve shown in FIG. 55B does not include a transducer connection, butinstead includes a vent 912.

FIG. 56 is a perspective view of one embodiment of a hand controllerthat may be used with a powered injection system, such as the system 600or system 700. This hand controller may be coupled to the system andused by a user to control the injection of fluid into a patient. In oneembodiment, the hand controller is a disposable component that isdiscarded after each patient procedure. In one embodiment, the handcontroller is reusable across multiple procedures.

The hand controller comprises a housing 1000, a first button 1002, and asecond button 1004. As shown, the housing 1000 is ergonomic, thin, andmay fit well into a palm of a user's hand. In one embodiment, thehousing 1000 is made of a plastic material, and the buttons 1002 and1004 are made of a flexible material, such as silicone or rubber. Theuser may press the button 1002 to inject a first fluid into the patient,such as saline. The user may press the button 1004 to inject a secondfluid into the patient, such as contrast. In one mode, the user maypress the button 1002 to inject a predetermined amount of fluid. In onemode, the user may press the button 1004 to inject a variable amount offluid at a variable flow rate, depending on how long and how hard theuser presses the button 1004. In one embodiment, the user may use thesame finger, such as a thumb, to press either the button 1002 or thebutton 1004. In one embodiment, the user may press the buttons 1002 and1004 at the same, or substantially the same, time using differentfingers. In one embodiment, the hand controller and correspondingbuttons are coupled to the injection system using a pneumatic interfaceor electronic interface. In other embodiments, other interfaces may beused. In one embodiment, the hand controller shown in FIG. 56 mayreplace the hand controller 14 shown in FIG. 1.

It will be appreciated that while preferred embodiment descriptions andapplications of the invention have been disclosed, other modificationsnot specifically disclosed or referred to herein will be apparent tothose skilled in the art in light of the foregoing description. Thisdescription is intended to provide specific examples of preferredembodiments, structures, methods, algorithms and applications.Accordingly, the invention is not limited to any particular embodimentor configuration or component parts thereof.

What is claimed is:
 1. A method of using contextual lighting to assist auser of a medical fluid injection system, the method comprising:providing a lighted display that is located adjacent to a component ofthe injection system to indicate where the component is physicallylocated in the injection system, wherein the component comprises atleast one of a fluid reservoir, a syringe, a valve, an air detector, ortubing; prior to initiating an injection procedure, causing the lighteddisplay to visually indicate that a setup function is to be performedfor the component in conjunction with a console of the injection systemproviding a graphical user interface (GUI) that displays a schematicgraphical representation of the component and setup instructions toinstruct the user that the setup function is to be performed for thecomponent, wherein the lighted display is distinct from the console thatprovides the GUI, wherein the lighted display visually indicates thatthe setup function is to be performed for the component while the GUIdisplays the schematic graphical representation of the component andalso displays the setup instructions to instruct the user that the setupfunction is to be performed for the component, and wherein the setupfunction is associated with an installation of the component in theinjection system; if the user has properly performed the setup functionthat is associated with the installation of the component in theinjection system, providing a first visual indication on the lighteddisplay prior to initiating the injection procedure and furtherdisplaying, in the GUI, a next setup instruction in the guided setupinstructions, wherein the first visual indication on the lighted displaycomprises at least one of blinking, changing color, changing from ablinking light to a non-blinking light, or changing from a non-blinkinglight to a blinking light; and if the user has not properly performedthe setup function that is associated with the installation of thecomponent in the injection system, providing a second visual indicationon the lighted display prior to initiating the injection procedure,wherein the second visual indication on the lighted display is differentfrom the first visual indication, and wherein the second visualindication on the lighted display comprises at least one of blinking,changing color, changing from a blinking light to a non-blinking light,or changing from a non-blinking light to a blinking light.
 2. The methodof claim 1, wherein the component comprises the tubing, wherein thesetup function associated with the installation of the component in theinjection system includes loading the tubing into the system prior toinitiating the injection procedure, and wherein the tubing is used tocarry fluid into or out of the injection system.
 3. The method of claim1, wherein the component comprises the valve, wherein providing thelighted display that is located adjacent to the component of theinjection system comprises providing the lighted display locatedadjacent to the valve.
 4. The method of claim 1, wherein the componentcomprises the air detector, wherein providing the lighted display thatis located adjacent to the component of the injection system comprisesproviding the lighted display located adjacent to the air detector. 5.The method of claim 1, wherein causing the lighted display to visuallyindicate that the setup function is to be performed for the componentcomprises causing the lighted display to do at least one of blink,change color, switch from a blinking light to a non-blinking light, andchange from a non-blinking light to a blinking light.
 6. A medical fluidinjection system, comprising: a console configured to receive input froma user and to provide a graphical user interface (GUI); and a lighteddisplay that is located adjacent to a component of the injection systemto indicate where the component is physically located in the injectionsystem, wherein the lighted display is distinct from the console thatprovides the GUI, and wherein the component comprises at least one of afluid reservoir, a syringe, a valve, an air detector, or tubing,wherein, prior to initiating an injection procedure, the lighted displayis configured to visually indicate that a setup function is to beperformed for the component in conjunction with the GUI displaying aschematic graphical representation of the component and setupinstructions in the GUI to instruct the user that the setup function isto be performed for the component, wherein the lighted display visuallyindicates that the setup function is to be performed for the componentwhile the GUI displays the schematic graphical representation of thecomponent and also displays the setup instructions to instruct the userthat the setup function is to be performed for the component, andwherein the setup function is associated with an installation of thecomponent in the injection system wherein if the user has properlyperformed the setup function that is associated with the installation ofthe component in the injection system, the lighted display is configuredto provide a first visual indication prior to initiating the injectionprocedure and to further display, in the GUI, a next setup instructionin the guided setup instructions, the first visual indication comprisingat least one of blinking, changing color, changing from a blinking lightto a non-blinking light, or changing from a non-blinking light to ablinking light, and wherein if the user has not properly performed thesetup function that is associated with the installation of the componentin the injection system, the lighted display is configured to provide asecond visual indication prior to initiating the injection procedure,the second visual indication being that is different from the firstvisual indication, and the second visual indication comprising at leastone of blinking, changing color, changing from a blinking light to anon-blinking light, or changing from a non-blinking light to a blinkinglight.
 7. The medical fluid injection system of claim 6, wherein thecomponent comprises the tubing, wherein the setup function associatedwith the installation of the component in the injection system includesloading the tubing into the injection system prior to initiating theinjection procedure, and wherein the tubing is used to carry fluid intoor out of the injection system.
 8. The medical fluid injection system ofclaim 6, wherein the component comprises the valve.
 9. The medical fluidinjection system of claim 6, wherein the component comprises the airdetector.
 10. The medical fluid injection system of claim 6, wherein thelighted display is configured to visually indicate that the setupfunction is to be performed by at least one of blinking, changing color,switching from a blinking light to a non-blinking light, or switchingfrom the non-blinking light to the blinking light.